Exactech, Inc.: GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 42, REF 106-22-42; b. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 44, REF 106-22-44; c. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 46, REF 106-22-46; d. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 48, REF 106-22-48; e. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 50, REF 106-22-50; f. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 52, REF 106-22-52; g. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 54, REF 106-22-54; h. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 48, REF 106-28-48; i. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 50, REF 106-28-50; j. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 52, REF 106-28-52; k. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 54, REF 106-28-54; l. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 56, REF 106-28-56; m. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 58, REF 106-28-58; n. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 60, REF 106-28-60; o. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 52, REF 106-32-52; p. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 54, REF 106-32-54; q. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 56, REF 106-32-56; r. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 58, REF 106-32-58; s. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 60, REF 106-32-60

Recall number

Z-1733-2022

Recalling firm

Exactech, Inc.

Product

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 42, REF 106-22-42; b. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 44, REF 106-22-44; c. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 46, REF 106-22-46; d. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 48, REF 106-22-48; e. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 50, REF 106-22-50; f. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 52, REF 106-22-52; g. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 54, REF 106-22-54; h. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 48, REF 106-28-48; i. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 50, REF 106-28-50; j. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 52, REF 106-28-52; k. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 54, REF 106-28-54; l. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 56, REF 106-28-56; m. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 58, REF 106-28-58; n. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 60, REF 106-28-60; o. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 52, REF 106-32-52; p. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 54, REF 106-32-54; q. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 56, REF 106-32-56; r. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 58, REF 106-32-58; s. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 60, REF 106-32-60

Status

Open, Classified

Initiated

2022-08-11

Posted

not on file

Terminated

not on file

Reason

Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.

Root cause

Process control

Action

The firm sent an "URGENT MEDICAL DEVICE RECALL" DEAR HEALTHCARE PROFESSIONAL COMMUNICATION on 08/11/2022 by email. The purpose of the current letter is to update surgeons regarding the implications of the packaging non-conformity on performance of the Connexion GXL and other conventional UHMWPE acetabular liners. In addition, this letter provides updates to patient management and follow-up recommendations since issuance of the July 2021 DHCP letter. In addition to providing surgeons with lists of all their affected GXL and/or conventional polyethylene patients since 2004, Exactech is providing surgeons with two draft letters directed at patients who have been implanted with Exactech GXL hip devices. The Customers were instructed to take the following actions: CAREFULLY REVIEW THIS RECALL NOTIFICATION to ensure that you fully understand the issue identified, the recall strategy, and all actions required. IMMEDIATELY IDENTIFY AND QUARANTINE any of the subject devices in your inventory and/or customers inventory. EXTEND THE DESCRIPTION OF THE ISSUE AND CLINICAL IMPACT as described in the recall notification to your accounts that may have this product in their possession. COMPLETE AND RETURN the attached Recall Inventory Response Form to Exactech via email at recalls@exac.com. Reach out to Customer Service at cust.svc@exac.com to request a Returned Goods (RG) Number for ALL affected product requested to be returned. WE ARE REQUIRING 100% EFFECTIVENESS FOR THIS RECALL. If you have any questions, call (888) 912-0403.

Quantity

4956 devices

Distribution

Worldwide distribution: US (nationwide) and OUS (foreign) countries of: ARGENTINA, BRAZIL, CHILE, CHINA, COLOMBIA, ECUADOR, GREECE, GUATEMALA, INDIA, LEBANON PORTUGAL,PUERTO RICO,SPAIN

Lot, serial or model codes

a. REF 106-22-42, GUDID 10885862014337, Serial Numbers: 609855, 609856, 609857, 609858, 609859, 609860, 609862, 609863, 609864, 609865, 609867, 609868, 609869, 609870, 609871, 609873, 609874, 609878, 609879, 609880, 914353, 914354, 914355, 914356, 914357, 914358, 914359, 914360, 914361, 914362, 914363, 914364, 996721, 996722, 996723, 996724, 996725, 996726, 996727, 996728, 996730, 996731, 996732, 996733, 996734, 996735, 996736, 996737, 996738, 996739, 1049244, 1049245, 1049246, 1049247, 1068758, 1068759, 1068760, 1068761, 1068762, 1068763, 1068765, 1068766, 1068767, 1068768, 1068769, 1068770, 1068771, 1068772, 1068773, 1068774, 1068775, 1068776, 1068777, 1068778, 1229946, 1229947, 1229948, 1229949, 1229950, 1229951, 1229952, 1229953, 1229954, 1229955, 1229956, 1332136, 1332137, 1332138, 1332139, 1332140, 1358473, 1358475, 1358476, 1358477, 1358478, 1514277, 1514278, 1514279, 1514280, 1514281, 1514282, 1514283, 1514284, 1514285, 1514286, 1514287, 1514288, 1514289, 1514290, 1514291, 1514292, 1514293, 1514296, 1695633, 1695634, 1695635, 1695636, 1695637, 1695638, 1695639, 1695640, 1695642, 1695643, 1695644, 1695645, 1695646, 1695647, 1695648, 1695649, 1695650, 1695651, 1695652, 1919868, 1919869, 1919870, 1919871, 1919872, 1919873, 1919874, 1919875, 2017771, 2017772, 2172423, 2172424, 2172425, 2180478, 2180479, 2180480, 2180481, 2221234, 2221235, 2221236, 2221238, 2276137, 2276138, 2276139, 2291938, 2291939, 2291940, 2291941, 2333843, 2333844, 2375620, 2375621, 2375622, 2375623, 2387651, 2426847, 2426848, 2426849, 2426851, 2426853, 2426857, 2426858, 2426860, 2426861, 2523731, 2523732, 2523733, 2523734, 2523735, 2523736, 2523737, 2523741, 2829861; b. REF 106-22-44, GUDID 10885862014344, Serial Numbers: 639981, 639983, 639984, 639985, 639987, 639988, 639991, 639992, 639993, 639996, 639997, 640000, 640001, 640003, 640004, 640005, 640006, 817951, 817952, 817953, 817954, 817955, 817956, 817957, 817958, 817959, 817960, 817961, 817962, 817963, 817964, 817965, 817966, 817967, 817968, 817969, 817970, 817971, 817972, 817973, 817974, 817975, 817976, 817977, 817978, 817979, 918337, 918338, 918339, 918340, 918341, 918342, 947926, 947927, 947928, 948966, 948967, 948968, 948969, 948970, 948971, 948972, 948973, 953468, 953469, 953470, 953471, 953472, 953473, 953474, 953475, 953476, 953477, 953478, 983886, 983887, 983889, 983890, 983891, 983892, 983893, 983894, 983895, 983896, 983897, 1030464, 1030465, 1030466, 1030467, 1030468, 1030469, 1030471, 1030472, 1030474, 1030475, 1063471, 1063472, 1063473, 1063474, 1063475, 1063476, 1063477, 1063478, 1063479, 1063480, 1091417, 1091418, 1091419, 1091420, 1091421, 1091422, 1091423, 1091424, 1091425, 1091426, 1091427, 1144552, 1144553, 1144554, 1144555, 1144556, 1144557, 1144558, 1144559, 1144560, 1144561, 1144562, 1144563, 1148822, 1148823, 1148824, 1148825, 1148826, 1148828, 1148829, 1148830, 1148831, 1148832, 1216991, 1216992, 1216993, 1216994, 1216995, 1216996, 1216997, 1216998, 1216999, 1217000, 1217001, 1331966, 1331967, 1331968, 1331969, 1331970, 1337238, 1337239, 1337240, 1337241, 1337242, 1338262, 1338263, 1338264, 1338265, 1338266, 1400016, 1400017, 1400018, 1400019, 1400020, 1508752, 1508753, 1508754, 1508755, 1508756, 1508757, 1508758, 1508759, 1508760, 1508761, 1508762, 1508764, 1508765, 1508766, 1508767, 1508768, 1546724, 1546725, 1546726, 1546727, 1546728, 1546729, 1546730, 1564097, 1564098, 1564099, 1564100, 1564101, 1564102, 1564103, 1564105, 1564106, 1564107, 1679331, 1679332, 1679333, 1679334, 1679335, 1679336, 1679337, 1679338, 1679339, 1679340, 1679341, 1679342, 1679343, 1679344, 1679347, 1679348, 1679351, 1679352, 1907549, 1907550, 1907552, 1907553, 1907554, 1907555, 1907556, 1907557, 1907558, 1907560, 1907561, 1907563, 1907564, 1907565, 1907566, 1907567, 1919619, 1919620, 1919621, 1919623, 2190916, 2190917, 2197909, 2197910, 2229307, 2230911, 2230920, 2260548, 2425073, 2425074, 2425075, 2425076, 2425077, 2579301, 2579302, 2579306, 2797305; c. REF 106-22-46, GUDID 10885862014351, Serial Numbers: 607057, 607058, 607062, 607065, 607066, 607067, 607069, 607073, 607074, 607079, 639619, 639621, 639622, 639623, 639624, 639625, 639626, 639627, 639628, 639629, 639630, 639631, 639632, 639633, 639635, 639636, 639637, 639638, 639640, 639641, 639642, 639643, 814278, 814279, 814280, 814281, 814282, 814283, 814284, 814285, 814286, 814287, 814288, 814289, 814290, 814291, 814292, 814293, 814294, 814295, 814296, 814297, 814298, 822453, 822454, 822455, 822457, 822458, 822459, 822460, 822461, 822464, 822465, 822466, 822467, 822468, 822469, 822470, 822471, 822472, 822473, 822474, 822475, 822476, 822477, 822478, 822479, 822480, 822481, 930825, 930827, 930828, 930829, 930831, 930832, 937984, 937985, 937986, 937987, 937988, 937989, 937990, 937991, 937992, 945802, 945803, 945804, 945805, 945806, 945807, 945808, 945809, 945810, 945811, 945812, 956906, 956907, 956908, 956909, 956910, 956911, 956912, 956913, 956914, 982576, 982577, 982578, 982579, 982580, 982581, 982582, 982584, 982585, 982586, 982587, 982588, 982589, 982590, 982591, 982592, 982593, 982594, 982595, 982596, 982597, 982598, 982599, 982600, 982601, 982602, 1020386, 1020387, 1020388, 1020389, 1020390, 1020391, 1020392, 1020393, 1020394, 1020395, 1020396, 1020397, 1040911, 1040912, 1040913, 1040914, 1040915, 1040916, 1040917, 1040918, 1040919, 1040920, 1040921, 1056598, 1056599, 1056600, 1056601, 1056602, 1056603, 1056604, 1056605, 1056606, 1056607, 1056608, 1084693, 1084694, 1084695, 1084696, 1084698, 1084699, 1084700, 1084701, 1084702, 1084703, 1084704, 1115005, 1115007, 1115008, 1115009, 1115010, 1115011, 1115012, 1115013, 1115014, 1115015, 1115016, 1115017, 1115018, 1115019, 1115020, 1115021, 1115022, 1115023, 1115024, 1115025, 1115026, 1195302, 1195303, 1195304, 1195305, 1195306, 1195308, 1195309, 1195310, 1195311, 1195313, 1231387, 1231388, 1231389, 1231390, 1231391, 1231392, 1231394, 1231395, 1231396, 1231398, 1295838, 1295839, 1295840, 1295841, 1295842, 1295843, 1295844, 1295845, 1295846, 1295848, 1295849, 1332944, 1332945, 1332946, 1332947, 1332948, 1332949, 1332950, 1332951, 1332952, 1367686, 1367687, 1367688, 1367689, 1367690, 1367691, 1367692, 1367693, 1367694, 1367695, 1367696, 1434641, 1434642, 1434643, 1434644, 1434645, 1434646, 1434647, 1434648, 1434649, 1434650, 1434651, 1434652, 1434653, 1434654, 1434655, 1434656, 1434657, 1434658, 1434659, 1528220, 1528221, 1528222, 1528223, 1528224, 1528225, 1528226, 1528227, 1528228, 1528229, 1540020, 1540021, 1540022, 1540023, 1540025, 1540026, 1746252, 1746253, 1746254, 1746255, 1746256, 1746257, 1746258, 1746259, 1746260, 1746261, 1746262, 1746263, 1761788, 1761789, 1761790, 1761791, 1761792, 1761793, 1761794, 1761796, 1761797, 1761798, 1761799, 1761800, 1761801, 1761802, 1761803, 1761804, 1761805, 1761806, 1761807, 1761808, 1761810, 1761811, 1761812, 1761813, 1761815, 1761816, 1827034, 1827035, 1827036, 1827037, 1827038, 1827039, 1827040, 1827041, 1919732, 1919733, 1919734, 1919735, 1919738, 1919740, 1919741, 1919742, 1919744, 1919745, 2190157, 2190158, 2190161, 2212091, 2245100, 2245101, 2245102, 2245103, 2245104, 2245105, 2245106, 2245107, 2357013, 2357014, 2357015, 2418195, 2418196, 2418198, 2418199, 2418200, 2481252, 2481255, 2481257, 2481258, 2481259, 2481260, 2575378, 2575383, 2575384; d. REF 106-22-48, GUDID 10885862014368, Serial Numbers: 947421, 947422, 947424, 947425, 947426, 947428, 947429, 947437, 947442, 947445, 1688077, 1688078, 1688079, 1688081, 1688083, 1688084, 2168203; e. REF 106-22-50, GUDID 10885862014375, Serial Numbers: 905492, 905497, 905499, 905500, 905503, 905505, 905514, 2062753, 2062757, 2062767, 2062773; f. REF 106-22-52, GUDID 10885862014382, Serial Numbers: 949166, 949171, 949173, 949174, 949176, 1970347, 1970348, 967454, 967459; h. REF 106-28-48, GUDID 10885862014603, Serial Numbers: 595247, 595248, 595249, 595250, 595251, 595252, 595253, 595254, 595255, 595256, 595258, 595259, 595260, 595261, 595262, 595263, 595264, 595265, 595266, 595267, 595268, 595269, 595270, 595271, 595272, 614753, 614754, 614755, 614756, 614757, 614758, 614759, 614760, 614761, 614762, 614763, 614764, 614765, 614766, 614767, 614768, 614769, 614770, 614771, 614772, 614773, 614774, 614775, 614776, 614777, 614778, 640037, 640038, 640039, 640040, 640041, 640043, 640044, 640045, 640046, 640047, 640048, 640049, 640050, 640051, 640052, 640053, 640054, 640055, 640056, 640057, 640058, 640059, 640060, 640061, 641727, 641728, 641732, 641733, 641734, 641735, 641736, 641738, 641739, 641740, 641741, 641742, 641743, 641744, 641745, 641746, 641747, 641749, 641750, 641751, 669109, 669110, 669111, 669112, 669113, 669114, 669115, 669116, 669118, 669119, 669120, 669121, 669123, 669124, 669125, 669126, 669127, 669128, 669130, 669131, 669133, 669134, 669135, 669136, 669137, 669138, 669139, 669140, 669141, 669142, 669143, 669145, 669146, 669147, 669148, 669149, 669150, 669151, 669152, 669153, 669155, 669156, 669157, 669159, 669160, 669161, 669162, 722795, 722801, 722803, 722804, 722805, 722806, 722807, 722808, 722809, 722811, 722813, 722814, 722815, 722816, 722817, 722818, 722819, 722820, 722821, 766147, 766148, 766149, 766150, 766151, 766152, 766153, 766154, 766155, 766156, 766157, 766158, 766159, 766160, 766161, 766162, 766163, 766164, 766165, 766166, 766167, 766168, 766170, 766171, 766172, 766173, 766174, 766175, 766176, 766177, 785164, 785165, 785166, 785167, 785168, 785169, 785170, 785171, 785172, 785173, 785174, 785175, 785176, 785177, 785178, 785179, 785180, 785181, 785182, 785183, 785184, 785185, 785186, 785187, 785188, 785189, 785190, 785191, 785192, 785193, 834529, 834530, 834531, 834532, 834533, 834534, 834535, 834536, 834537, 834538, 834540, 834541, 834542, 834543, 834544, 834545, 834546, 834547, 834548, 834549, 834550, 834551, 834552, 834553, 834554, 834555, 834556, 834557, 834558, 835047, 835048, 835049, 835050, 835051, 835052, 835053, 835054, 835055, 835056, 835057, 835058, 835059, 835060, 835061, 835062, 835063, 835064, 835065, 835066, 871522, 871523, 871524, 871525, 871526, 871527, 871528, 871529, 871530, 871531, 871532, 871533, 871534, 871535, 871536, 871537, 871538, 871539, 871540, 871541, 873630, 873632, 873635, 873636, 873637, 873638, 873639, 873641, 873642, 873644, 873646, 873647, 873648, 873649, 873650, 909097, 909099, 909100, 909101, 909102, 909103, 909104, 909105, 909106, 909107, 909109, 909110, 909111, 909289, 909290, 909291, 909292, 909293, 909294, 909295, 909296, 909297, 909298, 909299, 909302, 909303, 909305, 909306, 918295, 918296, 918297, 918298, 918299, 918300, 918301, 918302, 918303, 918304, 918305, 918306, 918307, 923172, 923173, 923174, 923175, 923176, 923177, 923178, 923179, 923180, 923181, 923182, 923183, 923184, 928326, 928327, 928328, 928329, 928330, 928331, 928332, 928333, 928334, 928335, 928336, 928337, 944453, 944455, 944456, 944457, 944459, 944460, 944461, 944462, 944463, 944464, 944465, 947882, 947883, 947884, 947885, 947886, 947887, 947888, 947889, 947890, 947891, 947892, 947893, 957589, 957590, 957591, 957592, 957593, 957594, 957595, 957596, 957597, 957598, 957599, 957600, 957601, 957602, 957603, 957604, 957605, 957606, 957607, 957608, 957609, 957610, 957611, 957612, 957613, 980744, 980745, 980746, 980747, 980748, 980749, 980750, 980751, 980752, 980753, 980754, 980755, 980756, 980757, 980758, 980759, 980760, 980761, 980762, 980763, 980764, 980765, 980766, 980767, 980768, 980769, 980770, 980953, 980954, 980955, 980956, 980957, 980958, 980959, 980961, 980962, 980963, 980964, 980965, 980966, 980967, 980968, 980969, 980970, 980971, 980972, 980973, 980974, 980975, 980976, 980977, 980978, 980979, 980980, 980981, 980982, 980983, 980984, 1003425, 1003426, 1003427, 1003428, 1003429, 1003430, 1003431, 1003432, 1003433, 1003434, 1003435, 1003436, 1003437, 1003438, 1003439, 1003440, 1003441, 1003442, 1003443, 1003444, 1003445, 1003446, 1003447, 1003448, 1003449, 1003450, 1023805, 1023806, 1023807, 1023808, 1023809, 1023810, 1023811, 1023812, 1023813, 1023814, 1023815, 1023817, 1023818, 1023819, 1023820, 1023821, 1023822, 1023823, 1023824, 1023825, 1023827, 1023828, 1023829, 1023830, 1023831, 1046008, 1046011, 1046012, 1046013, 1046014, 1046015, 1046016, 1046017, 1046018, 1046019, 1046020, 1046022, 1046023, 1046024, 1046025, 1046026, 1046027, 1046029, 1046030, 1046031, 1046032, 1046033, 1054487, 1054488, 1054489, 1054490, 1054491, 1054492, 1054493, 1054494, 1054495, 1054496, 1054497, 1063718, 1063719, 1063720, 1063721, 1063722, 1063723, 1063724, 1063725, 1063726, 1063727, 1063728, 1063729, 1063730, 1063731, 1063732, 1063733, 1063734, 1063735, 1063736, 1063737, 1063738, 1063739, 1063740, 1063741, 1063742, 1063743, 1063744, 1063746, 1063747, 1063748, 1063749, 1079571, 1079572, 1079573, 1079574, 1079575, 1079576, 1079577, 1079578, 1079579, 1079580, 1079581, 1079582, 1079583, 1079584, 1079585, 1079586, 1079587, 1079588, 1079589, 1079590, 1091543, 1091544, 1091545, 1091546, 1091547, 1091548, 1091549, 1091550, 1091551, 1091552, 1091553, 1091554, 1091555, 1091556, 1091557, 1091558, 1091559, 1091560, 1091562, 1113569, 1113570, 1113571, 1113572, 1113573, 1113574, 1113575, 1113576, 1113577, 1113578, 1113579, 1113580, 1113581, 1113582, 1113583, 1113584, 1113585, 1113586, 1113587, 1113589, 1113590, 1113591, 1113592, 1113593, 1113594, 1113595, 1113596, 1113597, 1113598, 1113599, 1113600, 1113601, 1147101, 1147102, 1147103, 1147104, 1147105, 1147106, 1147108, 1147109, 1147111, 1147112, 1159296, 1159297, 1159298, 1159299, 1159300, 1159301, 1159302, 1159303, 1159304, 1159305, 1159306, 1159307, 1159308, 1159309, 1159310, 1159311, 1159312, 1159313, 1159314, 1159316, 1159317, 1159318, 1159319, 1159320, 1159321, 1159322, 1159323, 1159324, 1159325, 1159326, 1159327, 1159328, 1159329, 1159330, 1159331, 1159332, 1159333, 1159334, 1159335, 1159336, 1159337, 1159338, 1159340, 1159341, 1189159, 1189160, 1189161, 1189162, 1189163, 1189164, 1189165, 1189166, 1189167, 1189168, 1189169, 1189170, 1189171, 1189172, 1189173, 1189174, 1189175, 1189176, 1189177, 1189178, 1189179, 1189180, 1189181, 1189182, 1189183, 1189184, 1189185, 1189186, 1189187, 1189188, 1189189, 1189190, 1189518, 1189521, 1189522, 1189523, 1189525, 1189526, 1189527, 1189528, 1189529, 1237792, 1237793, 1237794, 1237795, 1237796, 1237797, 1237798, 1237799, 1237800, 1237801, 1237802, 1237803, 1237804, 1237805, 1237806, 1260832, 1260833, 1260835, 1260836, 1260837, 1260838, 1260839, 1260840, 1260841, 1260842, 1260843, 1260844, 1260845, 1260846, 1276737, 1276738, 1276740, 1276742, 1276743, 1276744, 1276745, 1276746, 1276747, 1276749, 1276750, 1276751, 1276752, 1276753, 1276754, 1276755, 1276756, 1276757, 1276758, 1276759, 1276760, 1276762, 1276763, 1276764, 1276765, 1276766, 1276767, 1276768, 1276769, 1276771, 1299489, 1299490, 1299491, 1299492, 1299493, 1299494, 1299495, 1299496, 1299498, 1299499, 1299500, 1299502, 1299503, 1299504, 1299505, 1299506, 1299507, 1299508, 1299509, 1299510, 1299511, 1299512, 1299514, 1299515, 1299516, 1299517, 1332811, 1332812, 1332814, 1332815, 1332817, 1332818, 1332819, 1332820, 1332821, 1332822, 1332823, 1332824, 1332825, 1332826, 1332827, 1332828, 1332829, 1332830, 1332831, 1332832, 1332834, 1332835, 1332836, 1332837, 1332838, 1332839, 1332840, 1332841, 1332842, 1332843, 1332844, 1379920, 1379921, 1379922, 1379923, 1379924, 1379925, 1379926, 1379927, 1379928, 1379929, 1379930, 1379931, 1379932, 1379933, 1379936, 1379937, 1379938, 1379939, 1379940, 1379941, 1379942, 1379943, 1379944, 1379945, 1379946, 1379947, 1379948, 1379950, 1379951, 1380437, 1380438, 1380439, 1380441, 1380442, 1380443, 1380444, 1380445, 1380446, 1380447, 1380448, 1380449, 1380450, 1380451, 1380452, 1380453, 1380454, 1380455, 1380457, 1380458, 1380459, 1380460, 1380461, 1380462, 1380463, 1380464, 1380465, 1380466, 1380467, 1380468, 1380469, 1380471, 1380472, 1380473, 1380474, 1380475, 1380476, 1380477, 1380478, 1380479, 1422668, 1422669, 1422670, 1422671, 1422672, 1422673, 1422674, 1422677, 1422678, 1422679, 1422680, 1422681, 1422682, 1422683, 1422684, 1422685, 1422686, 1422687, 1422688, 1422689.1422690, 1422691, 1422692, 1422693, 1422694, 1422695, 1422696, 1422697, 1422698, 1422699, 1436601, 1436602, 1436603, 1436604, 1436605, 1436607, 1436608, 1436609, 1436610, 1436611, 1436612, 1436613, 1436614, 1436615, 1472630, 1472631, 1472632, 1472634, 1472635, 1472636, 1472637, 1472638, 1472639, 1472640, 1472642, 1472643, 1472644, 1472646, 1472647, 1472648, 1472649, 1472650, 1472651, 1472652, 1472653, 1472654, 1472655, 1472656, 1472657, 1472658, 1472659, 1495116, 1495117, 1495118, 1495119, 1495120, 1495121, 1495122, 1495123, 1495124, 1495126, 1495127, 1495129, 1495130, 1495131, 1495132, 1495133, 1495134, 1495135, 1495137, 1495138, 1495139, 1495140, 1495141, 1495142, 1495143, 1495144, 1495145, 1495146, 1495147, 1495148, 1495149, 1495150, 1495151, 1495152, 1495153, 1495154, 1495155, 1495156, 1495157, 1495158, 1495160, 1495161, 1495162, 1539268, 1539269, 1539270, 1539271, 1539272, 1539273, 1539274, 1539275, 1539276, 1539277, 1557051, 1557052, 1557053, 1557054, 1557055, 1557056, 1557057, 1557059, 1557060, 1600159, 1600160, 1600161, 1600162, 1600163, 1600164, 1600165, 1600166, 1600167, 1600168, 1600169, 1600170, 1600171, 1600172, 1600173, 1600174, 1600175, 1600176, 1600177, 1600179, 1600180, 1600181, 1600182, 1600183, 1600184, 1600185, 1600186, 1600187, 1603039, 1603040, 1603041, 1603042, 1603043, 1603044, 1603045, 1603046, 1603049, 1603050, 1603051, 1603052, 1603053, 1603054, 1603055, 1603056, 1603057, 1603058, 1603059, 1603060, 1603061, 1603062, 1645107, 1645108, 1645109, 1645110, 1645111, 1645112, 1645113, 1645114, 1645115, 1645116, 1645117, 1645118, 1645119, 1645120, 1645121, 1645122, 1645123, 1645124, 1645125, 1645126, 1645127, 1645128, 1645129, 1645130, 1645131, 1645132, 1645133, 1645134, 1645135, 1645136, 1645137, 1645138, 1645139, 1645140, 1645141, 1673735, 1673736, 1673737, 1673738, 1673739, 1673740, 1673741, 1673742, 1673743, 1673744, 1673745, 1673746, 1673747, 1673748, 1673749, 1673750, 1673751, 1673752, 1673753, 1673754, 1673755, 1714664, 1714665, 1714666, 1714667, 1714668, 1714669, 1714670, 1714671, 1714672, 1714673, 1714674, 1714675, 1714676, 1714677, 1714678, 1714679, 1714680, 1714681, 1714682, 1714683, 1714684, 1714685, 1714686, 1714687, 1714688, 1714689, 1714690, 1714691, 1714692, 1714693, 1714694, 1714695, 1714696, 1714697, 1714698, 1714699, 1714700, 1714701, 1714702, 1714703, 1737913, 1737914, 1737915, 1737916, 1737917, 1737918, 1737919, 1737920, 1737921, 1737922, 1737923, 1737924, 1737925, 1737926, 1737927, 1737928, 1737929, 1737930, 1737931, 1737932, 1737933, 1737934, 1752696, 1752697, 1752698, 1752699, 1752700, 1752701, 1752702, 1752703, 1752704, 1752705, 1752707, 1752708, 1752709, 1752710, 1752711, 1752712, 1752713, 1752714, 1752715, 1752716, 1752717, 1752718, 1756145, 1756146, 1756148, 1756149, 1756150, 1756151, 1756152, 1756153, 1756154, 1756155, 1756156, 1756157, 1756158, 1756159, 1756160, 1756161, 1756162, 1756164, 1756165, 1756166, 1756167, 1756168, 1756169, 1835155, 1835156, 1835157, 1835158, 1835159, 1835160, 1835161, 1835162, 1835164, 1835165, 1835166, 1835167, 1835168, 1835169, 1835170, 1835172, 1835174, 1835175, 1835177, 1835178, 1835179, 1835180, 1835181, 1835182, 1835183, 1835184, 1835185, 1835186, 1835187, 1835188, 1835189, 1835190, 1835191, 1835192, 1835193, 1835194, 1835195, 1835196, 1835197, 1835198, 1835199, 1835200, 1835201, 1835233, 1835234, 1835235, 1835236, 1835237, 1835238, 1835239, 1835240, 1835241, 1835242, 1835243, 1835244, 1835245, 1835246, 1835247, 1835248, 1835249, 1835250, 1835251, 1835252, 1835253, 1835254, 1835255, 1835256, 1835257, 1835258, 1835259, 1835261, 1835262, 1835263, 1835264, 1835265, 1835266, 1835267, 1835268, 1835269, 1835270, 1853054, 1853055, 1853056, 1853057, 1853058, 1853059, 1853060, 1853061, 1853062, 1853063, 1853064, 1853066, 1853067, 1853068, 1853069, 1853070, 1853071, 1853072, 1924397, 1924398, 1924399, 1924400, 1924402, 1924403, 1924405, 1924410, 1924411, 1924412, 1924413, 1924414, 1924415, 1924417, 1924418, 1924419, 1924420, 1924528, 1924529, 1924530, 1924531, 1924532, 1924533, 1924534, 1924535, 1924536, 1924537, 1924538, 1924539, 1924540, 1924541, 1924542, 1924543, 1924544, 1924545, 1924546, 1924547, 1924548, 1924549, 1924550, 1924551, 1924552, 2000985, 2000986, 2000987, 2000988, 2000989, 2000990, 2000991, 2000992, 2000993, 2000994, 2000995, 2000996, 2000997, 2000998, 2000999, 2001000, 2001001, 2001002, 2001003, 2001004, 2001005, 2001006, 2012063, 2012064, 2012066, 2012067, 2012068, 2012069, 2012070, 2012071, 2012072, 2012073, 2012074, 2012075, 2012076, 2012077, 2012078, 2012079, 2012080, 2012081, 2012082, 2012083, 2012084, 2012085, 2012086, 2012087, 2012090, 2012091, 2026323, 2026324, 2026325, 2026326, 2026327, 2026328, 2026329, 2026330, 2026331, 2026332, 2026333, 2026334, 2026335, 2026336, 2026337, 2026338, 2026339, 2026340, 2026341, 2026342, 2048839, 2048840, 2048841, 2048842, 2048843, 2048844, 2048845, 2048846, 2048847, 2048848, 2048849, 2048850, 2048851, 2048852, 2048853, 2048854, 2048855, 2048856, 2048857, 2048858, 2241438, 2241439, 2241440, 2241441, 2241442, 2241443, 2241444, 2241445, 2241446, 2241447, 2241448, 2241449, 2241450, 2241451, 2241452, 2241453, 2241454, 2241455, 2241456, 2241457, 2241458, 2241459, 2241460, 2241461, 2241462, 2241463, 2241464, 2241465, 2241466, 2241467, 2291709, 2291710, 2291711, 2291713, 2291714, 2291715, 2291716, 2291717, 2291718, 2291719, 2291720, 2291721, 2291723, 2291724, 2291725, 2291726, 2314707, 2314708, 2314709, 2314710, 2314711, 2314712, 2314713, 2314715, 2314716, 2314717, 2314718, 2314720, 2314721, 2314722, 2314723, 2314724, 2398418, 2398419, 2398420, 2398421, 2398422, 2398423, 2405530, 2405531, 2405532, 2405534, 2405535, 2405536, 2405537, 2405538, 2405539, 2405540, 2405541, 2405542, 2405543, 2405544, 2405545, 2405546, 2405547, 2405548, 2405549, 2405550, 2405551, 2405552, 2405553, 2405554, 2405555, 2405556, 2405557, 2405558, 2405559, 2405560, 2405562, 2405563, 2405564, 2405565, 2405566, 2468070, 2468071, 2468072, 2468073, 2468074, 2468075, 2468076, 2468077, 2468078, 2468079, 2468080, 2468081, 2468082, 2468083, 2468084, 2468085, 2468086, 2468087, 2468088, 2468089, 2468090, 2468091, 2468092, 2468093, 2537329, 2537330, 2537331, 2537332, 2537333, 2537334, 2537335, 2537336, 2537337, 2537338, 2537339, 2537340, 2537341, 2537342, 2537343, 2537344, 2537345, 2537346, 2537347, 2537348, 2537349, 2537350, 2537351, 2537352, 2537353, 2537354, 2537355, 2537356, 2537357, 2537358, 2537359, 2537360, 2537361, 2537362, 2537363, 2537364, 2537365, 2537366, 2537367, 2537368, 2537369, 2537370, 2537371, 2575385, 2575386, 2575387, 2575388, 2575389, 2575390, 2575391, 2575392, 2575393, 2575394, 2575395, 2575396, 2575397, 2575398, 2575399, 2575401, 2575403, 2575404, 2575405, 2575406, 2575407, 2575408, 2575409, 2575410, 2849245, 2849246, 2849247, 2849248, 2849249, 2849251, 2849252, 2849253, 2849254, 2849255, 2849256, 2849257, 2849258, 2849259, 2849260, 2849261, 2849262, 2849263, 2849264, 2849265, 2849267, 2849268, 2849269, 2849270, 2959363, 2959365, 2959366, 2959367, 2959368, 2959369, 2959370, 2959372, 2959373, 2978295, 2978296, 2978297, 2978298, 2978299, 2978300, 2978301, 2978302, 2978303, 2978304, 2978305, 2978307, 2978308, 3536218, 3536219, 3536220, 3536223, 3536224, 3536225, 3536226, 3536229, 3536230, 3536231, 3536234, 3536237, 3536238, 3536240, 3707448, 3707450, 3707452, 3707454, 3707456, 3707457, 3812884, 3812885, 3812886, 3812887, 3812888, 3812889, 3812890, 3812891, 3812892, 3812893, 3812894, 3812895, 3862847, 3862848, 3862849, 3862850, 3862851, 3862852, 3862853, 3862854, 3862855, 3862856, 3862857, 3862859, 3862860, 3862861, 3862862, 3862864, 4086226, 4086227, 4086228, 4086229, 4086230, 4086231, 4086232, 4086233, 4086234, 4086235, 4086236, 4086237, 4162297, 4162298, 4162299, 4162300, 4162301, 4162302, 4162303, 4162304, 4162306, 4162307, 4162308, 4162309, 4162310, 4162311, 4162312, 4162313, 4162314, 4162315, 4162316, 4162317, 4162318, 4162319, 4162320, 4162321, 4162322, 4162323, 4321334, 4321335, 4321336, 4321337, 4321338, 4321339, 4321340, 4321341, 4321342, 4321343, 4321344, 4321345, 4321346, 4321347, 4321348, 4321349, 4321350, 4321351, 4321352, 4321353, 4476701, 4476702, 4476703, 4476704, 4476705, 4476706, 4476707, 4476708, 4476709, 4476710, 4476711, 4476712, 4476713, 4476714, 4476715, 4476716, 4476717, 4476718, 4672669, 4672670, 4672671, 4672672, 4672673, 4672674, 4672675, 4672676, 4672677, 4672678, 4672679, 4672680, 4672681, 4672682, 4672683, 4672684, 4672685, 4672686, 4672687, 4672689, 4672690, 5145624, 5145625, 5145626, 5145627, 5145628, 5145629, 5145630, 5145631, 5145632, 5145633, 5262539, 5262542, 5262543, 5262546, 5262547, 5262548, 5262549, 5262551; i. REF 106-28-50, GUDID 10885862014610, Serial Numbers: 598300, 598301, 598302, 598303, 598304, 598305, 598307, 598310, 598311, 598312, 598313, 598314, 598315, 598316, 598318, 598319, 598321, 598323, 598324, 622440, 622441, 622442, 622443, 622444, 622445, 622446, 622447, 622448, 622450, 622451, 622452, 622453, 622454, 622455, 622456, 622457, 622458, 622459, 622460, 643323, 643324, 643325, 643326, 643328, 643329, 643330, 643331, 643332, 643333, 643334, 643335, 643336, 643338, 643339, 643340, 643341, 643343, 643344, 643345, 643346, 643347, 643348, 676868, 676869, 676870, 676871, 676872, 676873, 676875, 676876, 676877, 676878, 676879, 676880, 676882, 676883, 676884, 676885, 676886, 676887, 676888, 676890, 676892, 676893, 676894, 676895, 676896, 676897, 676898, 676899, 676901, 676902, 676903, 676904, 676905, 676906, 676908, 676909, 676910, 676911, 676912, 676913, 676914, 676915, 676916, 676917, 676918, 676919, 777095, 777096, 777099, 777100, 777101, 777102, 777103, 777104, 777105, 777106, 777107, 777108, 777109, 777110, 777111, 777112, 777113, 777114, 777115, 777116, 777117, 777118, 777119, 777120, 777122, 785363, 785364, 785365, 785366, 785367, 785368, 785369, 785370, 785371, 785372, 785373, 785374, 785376, 785378, 785379, 785380, 785381, 785382, 785383, 785384, 845487, 845488, 845489, 845490, 845491, 845492, 845493, 845494, 845495, 845496, 845498, 845499, 845501, 845502, 845503, 845504, 845506, 845508, 845744, 845745, 845746, 845747, 845748, 845749, 845750, 845752, 845753, 845754, 845755, 845756, 845757, 845758, 845759, 845760, 845762, 845763, 845765, 845766, 845767, 845768, 845771, 845772, 845773, 845774, 845775, 943041, 943043, 943044, 943045, 943046, 943048, 943149, 943150, 943151, 943152, 943153, 943154, 968773, 968774, 968775, 968776, 968777, 968778, 968779, 968780, 968782, 995692, 995693, 995694, 995695, 995696, 995697, 995698, 995699, 995700, 995701, 995702, 995703, 995704, 995705, 995706, 995707, 995708, 995709, 995710, 995711, 995712, 995713, 995714, 995715, 995716, 995717, 995718, 995719, 995720, 995721, 995722, 1026593, 1026594, 1026595, 1026596, 1026597, 1026598, 1026599, 1026600, 1026601, 1026602, 1026603, 1026604, 1026606, 1026607, 1026608, 1026609, 1054364, 1054365, 1054366, 1054368, 1054369, 1054370, 1054371, 1054372, 1054373, 1054374, 1055253, 1055254, 1055255, 1055256, 1055257, 1072647, 1072648, 1072649, 1072650, 1072651, 1072652, 1072653, 1072654, 1072655, 1072656, 1072657, 1072658, 1072659, 1072660, 1072662, 1072663, 1072664, 1072665, 1072666, 1072667, 1072668, 1091400, 1091401, 1091402, 1091403, 1091404, 1091405, 1091406, 1091407, 1091408, 1091409, 1091410, 1091411, 1091412, 1091413, 1091414, 1091416, 1106177, 1106178, 1106179, 1106180, 1106181, 1106182, 1106184, 1106186, 1106187, 1106188, 1116976, 1116977, 1116978, 1116979, 1116980, 1116981, 1116983, 1116984, 1116985, 1116986, 1116988, 1116989, 1116990, 1116991, 1116992, 1122280, 1122281, 1122282, 1122283, 1122284, 1122285, 1122286, 1122288, 1122289, 1122290, 1122291, 1159487, 1159488, 1159489, 1159490, 1159491, 1159492, 1159493, 1159494, 1159495, 1159496, 1159497, 1159498, 1159499, 1159500, 1159501, 1159502, 1201388, 1201389, 1201390, 1201391, 1201392, 1201393, 1201395, 1201396, 1201397, 1201398, 1201399, 1201400, 1201401, 1201402, 1201403, 1201404, 1201405, 1227839, 1227840, 1227842, 1227843, 1227844, 1227845, 1227846, 1227848, 1227849, 1227850, 1227851, 1227852, 1227853, 1227854, 1233275, 1233276, 1233277, 1233278, 1233279, 1233280, 1233281, 1233282, 1233283, 1233284, 1233285, 1233286, 1233288, 1233289, 1233290, 1233291, 1233292, 1233293, 1233294, 1233295, 1233296, 1233297, 1233298, 1233299, 1233300, 1233302, 1233303, 1276058, 1276059, 1276060, 1276061, 1276062, 1276063, 1276064, 1276065, 1276066, 1276067, 1276068, 1276069, 1294949, 1294950, 1294951, 1294953, 1294954, 1294955, 1294956, 1294957, 1294958, 1294959, 1294960, 1294961, 1294963, 1332059, 1332060, 1332061, 1332062, 1332063, 1332064, 1332065, 1332066, 1332067, 1332068, 1332069, 1332070, 1332071, 1332072, 1332073, 1332074, 1332075, 1369611, 1369612, 1369613, 1369614, 1369615, 1369616, 1369618, 1369619, 1369620, 1369621, 1369622, 1369623, 1369625, 1369626, 1369627, 1369628, 1369629, 1369630, 1369631, 1369632, 1369634, 1369635, 1369636, 1369637, 1369639, 1369640, 1369641, 1484400, 1484401, 1484402, 1484403, 1484404, 1484405, 1484406, 1484407, 1484408, 1484409, 1484410, 1484411, 1484412, 1504127, 1504128, 1504129, 1504130, 1504131, 1504132, 1504134, 1504135, 1504136, 1504137, 1504139, 1504140, 1504141, 1504144, 1504146, 1504147, 1504148, 1517230, 1517231, 1517232, 1517233, 1517234, 1517235, 1517236, 1517237, 1517238, 1517239, 1517240, 1605945, 1605947, 1605948, 1605949, 1605950, 1605951, 1605952, 1605953, 1605954, 1605955, 1605956, 1605957, 1605959, 1605960, 1607881, 1607882, 1607883, 1607884, 1607885, 1607886, 1607887, 1607888, 1607889, 1607890, 1607891, 1607892, 1607893, 1607894, 1607895, 1607896, 1607897, 1607898, 1607899, 1607900, 1607901, 1607902, 1607903, 1607904, 1607905, 1607906, 1607907, 1607908, 1607909, 1607910, 1607911, 1659558, 1659559, 1659560, 1659562, 1659563, 1659564, 1659565, 1659566, 1659567, 1659568, 1659569, 1659570, 1659571, 1659572, 1659574, 1659575, 1659576, 1659577, 1659578, 1745805, 1745806, 1745807, 1745808, 1745809, 1745810, 1745811, 1745812, 1745813, 1745814, 1745815, 1745816, 1745817, 1745818, 1745819, 1745820, 1745821, 1745822, 1745823, 1745824, 1745826, 1745827, 1745829, 1745831, 1745832, 1745833, 1745834, 1745835, 1745836, 1745837, 1745838, 1745839, 1745840, 1745841, 1745842, 1745843, 1745844, 1762027, 1762028, 1762029, 1762030, 1762031, 1762032, 1762033, 1762034, 1762035, 1762036, 1762037, 1762038, 1762040, 1762041, 1762042, 1762043, 1762044, 1784861, 1784862, 1784863, 1784865, 1784866, 1784867, 1784868, 1784869, 1784870, 1812666, 1812668, 1812669, 1812671, 1812675, 1812676, 1812677, 1812679, 1812680, 1812683, 1909088, 1909089, 1909090, 1909091, 1909092, 1909093, 1909094, 1909095, 1909097, 1911592, 1911593, 1911594, 1911595, 1911596, 1911597, 1911598, 1911599, 1911600, 1911601, 1911602, 1911603, 1911604, 1911605, 1911606, 1911607, 1911608, 1911609, 1911612, 1911613, 1911616, 2026916, 2026917, 2026918, 2026919, 2026920, 2173767, 2173768, 2173770, 2173771, 2173772, 2173773, 2173774, 2173775, 2188826, 2188827, 2188828, 2188830, 2188831, 2188832, 2188833, 2188834, 2188835, 2188837, 2188838, 2188840, 2188841, 2188842, 2188843, 2188844, 2188845, 2221687, 2221688, 2221689, 2221690, 2221691, 2221692, 2221693, 2221694, 2221696, 2221697, 2221698, 2221699, 2221700, 2221701, 2221702, 2221703, 2221704, 2221705, 2277455, 2277456, 2277458, 2277459, 2277460, 2277461, 2277462, 2277463, 2277464, 2277465, 2314391, 2314392, 2314393, 2314396, 2314397, 2314398, 2314399, 2420460, 2420461, 2420462, 2420463, 2420464, 2420465, 2420466, 2420467, 2420468, 2420469, 2420470, 2420471, 2420472, 2420473, 2420474, 2420475, 2420476, 2420477, 2420478, 2420479, 2505298, 2505299, 2505301, 2505302, 2505303, 2505304, 2505306, 2505308, 2505309, 2505310, 2505311, 2505312, 2505313, 2505316, 2505318, 2505319, 2505320, 2505321, 2505322, 2575411, 2575412, 2575413, 2575414, 2575415, 2575416, 2575417, 2575418, 2575419, 2575420, 2575422, 2575423, 2575424, 2575425, 2575426, 2575427, 2797359, 2797360, 2797362, 2797363, 2797364, 2797366, 2797367, 2797368, 2849271, 2849272, 2849273, 2849274, 2849275, 2849276, 2849277, 2849278, 2849280, 2849281, 2849282, 2849283, 2849284, 2849285, 2849286, 2849287, 2849288, 2849289, 2849290, 2849291, 2849292, 2849293, 2849294, 2849295, 2849296, 2953208, 2995324, 2995326, 2995329, 2995332, 2995333, 2995335, 2995336, 2995339, 2995341, 2995342, 2995343, 3990939, 4028350, 4028351, 4028352, 4028353, 4028354, 4028355, 4028356, 4028357, 4028358, 4028359, 4207498, 4207499, 4207500, 4207501, 4207502, 4207503, 4207504, 4207505, 4207506, 4207507, 4207508, 4207509, 4207510, 4207511, 4207512, 4207513, 4207514, 4207515, 4207516, 4207517, 4618012, 4618013, 4618014, 4618015, 4618016, 4618017, 4618018, 4949457, 4949458, 4949459, 4949460, 4949461, 4949463, 4949464, 5348939, 5348940, 5348941, 5779137, 5779138, 5779139, 5779140, 5779141; j. REF 106-28-52, GUDID 10885862014627, Serial Numbers: 624834, 624835, 624836, 624837, 624838, 624839, 624840, 624841, 624842, 624844, 624845, 624847, 624848, 624849, 624851, 624852, 624857, 701529, 701531, 701532, 701534, 701539, 701540, 701541, 701542, 701543, 701544, 701547, 701548, 701550, 701552, 737147, 737148, 737150, 737151, 737152, 737153, 737156, 737157, 737158, 737161, 737162, 737163, 737164, 737165, 737166, 737167, 737168, 737169, 737171, 737172, 737173, 737174, 737175, 737177, 737178, 737179, 737180, 737181, 778806, 778809, 778810, 778811, 778814, 778815, 887234, 887235, 887236, 887237, 887238, 887239, 887240, 887241, 887242, 887243, 887244, 887245, 887247, 887248, 887249, 887250, 887251, 887252, 887253, 887254, 936862, 936863, 936864, 936865, 936866, 936867, 936868, 936869, 936870, 936871, 936872, 936873, 936874, 936875, 936876, 936877, 936880, 936882, 936883, 936884, 936885, 936886, 936887, 936888, 936889, 991967, 991968, 991969, 991970, 991971, 991972, 991973, 991974, 991975, 991976, 991977, 991978, 991979, 991980, 991981, 991982, 991983, 991984, 991985, 991986, 991987, 991988, 1036375, 1036376, 1036378, 1036379, 1036380, 1036382, 1036384, 1036385, 1036386, 1056609, 1056610, 1056612, 1056614, 1056616, 1056617, 1056618, 1056619, 1056620, 1083462, 1083463, 1083465, 1083466, 1083467, 1083468, 1083469, 1083471, 1083472, 1083473, 1084139, 1084140, 1084141, 1084142, 1084143, 1084144, 1084145, 1084146, 1084147, 1084148, 1084149, 1113912, 1113913, 1113914, 1113915, 1113916, 1113917, 1113918, 1113919, 1113920, 1113921, 1113922, 1113923, 1113924, 1113925, 1113926, 1113927, 1113928, 1113930, 1113931, 1113932, 1142104, 1142105, 1142106, 1142107, 1142108, 1142109, 1142111, 1142115, 1142116, 1142117, 1142118, 1232904, 1232905, 1232906, 1232907, 1232908, 1232909, 1232910, 1232911, 1232912, 1232913, 1232914, 1232915, 1255872, 1255873, 1255874, 1255875, 1255876, 1255877, 1255878, 1255879, 1255880, 1255881, 1255882, 1255883, 1255884, 1255885, 1255886, 1255887, 1292783, 1292784, 1292785, 1292787, 1292788, 1292789, 1292790, 1292791, 1295474, 1295476, 1295477, 1295478, 1295480, 1295481, 1295482, 1295483, 1295484, 1295485, 1295486, 1295487, 1295488, 1295489, 1295492, 1295493, 1295495, 1357268, 1357269, 1357270, 1357271, 1357272, 1357273, 1357274, 1357275, 1357276, 1357277, 1357278, 1357279, 1357280, 1357281, 1357282, 1357283, 1357284, 1357285, 1357286, 1357288, 1357289, 1357290, 1512865, 1512866, 1512867, 1512869, 1600241, 1600242, 1600243, 1600244, 1600245, 1600246, 1600247, 1600248, 1600249, 1600251, 1600252, 1600253, 1600254, 1682404, 1682405, 1682406, 1682407, 1682408, 1682409, 1682410, 1682412, 1682413, 1682414, 1682415, 1682416, 1682417, 1682418, 1682419, 1682420, 1682421, 1682422, 1682423, 1682424, 1751522, 1751524, 1751525, 1751526, 1751527, 1751529, 1751530, 1751532, 1751535, 1751536, 1751537, 1751538, 1751539, 1751540, 1751541, 1785538, 1831193, 1874836, 1874837, 1874841, 1919352, 1919353, 1919354, 1919355, 1919356, 1919357, 1919358, 1919360, 1942275, 1942277, 1942278, 1942279, 1942280, 1942281, 1942283, 1976744, 1976745, 1976746, 1976747, 1976748, 2012146, 2012150, 2012152, 2012154, 2154770, 2154771, 2154772, 2198690, 2198691, 2198693, 2198694, 2198695, 2198696, 2198697, 2198698, 2198700, 2198701, 2229699, 2229701, 2229702, 2229704, 2229705, 2229706, 2229707, 2286230, 2286232, 2286233, 2286236, 2286237, 2286239, 2286240, 2286243, 2313853, 2313854, 2313857, 2313859, 2550725, 2550726, 2550727, 2550728, 2550729, 2680515, 2680516, 2957579, 2957583, 2957585, 2957586, 2994374, 2994375, 2994376, 2994378, 2994379, 2994380, 2994381, 2994383, 3625601, 3625602, 3625603, 3625606, 3625607, 3625608, 3628749, 3628751, 3808834, 3808835, 3808836, 3808837, 3808838, 3808839, 3951431, 3951432, 3951433, 3969386, 3991109, 3991110, 4016865, 4040039, 4040040, 4127637, 4221147, 4221148, 4221151, 4221157, 4221158, 4221164, 4221166; k. REF 106-28-54, GUDID 10885862014634, Serial Numbers: 650145, 650146, 650147, 650148, 650149, 650150, 650152, 650153, 650154, 650155, 650156, 650158, 650159, 650161, 650162, 650164, 650166, 668863, 668864, 668865, 668866, 668867, 668868, 668870, 668871, 668872, 668873, 668877, 668879, 668882, 668883, 668884, 668885, 668886, 668888, 668889, 668890, 668893, 668894, 668895, 668897, 668898, 668899, 668902, 668903, 668904, 668905, 668906, 668907, 668908, 668909, 668910, 668911, 668913, 668914, 668915, 668917, 723074, 723075, 723077, 723078, 723080, 723082, 723083, 723087, 723088, 723089, 723090, 723092, 723096, 723097, 723099, 1045227, 1045228, 1045229, 1045230, 1045231, 1045232, 1045233, 1045234, 1045235, 1045236, 1045237, 1071317, 1071318, 1071319, 1071320, 1071321, 1071322, 1071323, 1071324, 1071325, 1071326, 1071327, 1118212, 1118213, 1118214, 1118215, 1118216, 1118217, 1118218, 1118220, 1118221, 1118222, 1152323, 1152324, 1152325, 1152327, 1152328, 1152330, 1152331, 1152332, 1152335, 1152336, 1152337, 1152338, 1152340, 1152341, 1152343, 1152344, 1152345, 1152346, 1152347, 1152348, 1152349, 1152350, 1152351, 1152352, 1152353, 1152355, 1152356, 1152357, 1152358, 1152359, 1152360, 1152361, 1152362, 1152363, 1152364, 1152365, 1152456, 1152457, 1152458, 1152459, 1152460, 1152461, 1152462, 1152463, 1152464, 1152465, 1152466, 1152467, 1292813, 1292814, 1292815, 1292817, 1292818, 1292820, 1292821, 1292822, 1292823, 1292824, 1330914, 1330915, 1330916, 1330917, 1330918, 1330920, 1330921, 1330922, 1330923, 1330924, 1330925, 1358323, 1358327, 1358328, 1358330, 1358331, 1383072, 1383073, 1383074, 1383076, 1383077, 1383078, 1383081, 1383082, 1383083, 1383084, 1683412, 1683413, 1683414, 1683415, 1683416, 1683417, 1683418, 1683420, 1683422, 1683424, 1683425, 1683426, 1683427, 1683428, 1683429, 1683430, 1683431, 1683432, 1683433, 1683434, 1683435, 1683439, 1683442, 1874852, 1874856, 1874859, 1874860, 1874863, 1978709, 1978710, 1978711, 1978713, 1978714, 1978715, 1978716, 1978717, 1978718, 1978719, 1978720, 2162602, 2162604, 2209786, 2209787, 2209788, 2209789, 2209790, 2209791, 2209792, 2209793, 2240669, 2240671, 2240674, 2276226, 2276227, 2276228, 2481262, 2481266, 2481268, 2481272, 2550721, 2550722, 2550723, 2550724, 2825110, 2825111, 2825112, 2976263, 2976264, 2976265, 2994573, 2994576, 3551150, 3551153, 3551154, 3551155, 3551158, 3551160, 3951442, 3951443, 3951444, 3951445, 3951446, 3952183, 3952186, 3952187, 3952188, 3952194, 3952195, 3952196, 3952198, 3952199, 3952201; l. REF 106-28-56, GUDID 10885862014641, Serial Numbers: 677530, 677531, 677532, 677533, 677536, 677537, 677538, 677539, 677540, 677541, 677542, 677543, 677545, 677546, 677548, 677549, 677551, 723518, 723519, 723520, 723522, 723523, 723524, 723526, 723527, 723529, 723531, 723536, 723537, 723539, 723540, 723541, 723542, 723543, 723544, 980814, 980815, 980817, 980818, 980819, 980821, 980822, 980823, 1032686, 1032687, 1032688, 1032689, 1032690, 1032691, 1032692, 1032693, 1032694, 1032695, 1032696, 1032697, 1032698, 1032699, 1032700, 1032701, 1032702, 1032703, 1032704, 1032705, 1095124, 1095125, 1095126, 1095127, 1095128, 1095129, 1095130, 1095131, 1095132, 1095134, 1095135, 1095136, 1095137, 1095138, 1095139, 1095140, 1095141, 1095142, 1095143, 1226281, 1226282, 1226283, 1226284, 1226285, 1226286, 1226287, 1226288, 1226289, 1226290, 1226291, 1226292, 1226293, 1226294, 1226295, 1226296, 1226297, 1226298, 1226299, 1226300, 1226301, 1226302, 1226303, 1364467, 1364468, 1364469, 1364470, 1364471, 1364472, 1364473, 1364474, 1364475, 1364476, 1364479, 1364480, 1364481, 1364482, 1364483, 1364484, 1364485, 1364486, 1600211, 1600213, 1600214, 1600215, 1600216, 1627370, 1627371, 1627372, 1627373, 1627374, 1627376, 1627377, 1682493, 1682494, 1682495, 1682497, 1682499, 1682500, 1682501, 1682503, 1682504, 1682506, 1829912, 1829913, 1875403, 1875404, 1875406, 1875408, 1875409, 1875410, 1875411, 1976016, 1976017, 1976018, 1976019, 1976020, 1976023, 1976024, 2010927, 2198640, 2198641, 2217616, 2217618, 2217621, 2278658, 2278660, 2278661, 2278663, 2278664, 2278666, 2278667, 2550792, 2550793, 2550794, 2550796, 2680518, 2849301, 2849302, 2849303, 2849304, 2849306, 2849307, 2849308, 3614920, 3614921, 3614922, 3614923, 3664716, 3796669, 3796670, 3796671, 3796672, 3796673, 3796675, 3796676, 3796677, 3796678, 3796680; m. REF 106-28-58, GUDID 10885862014658, Serial Numbers: 668218, 668219, 668220, 668221, 668222, 668223, 668224, 668226, 668228, 668229, 668230, 668231, 668233, 668237, 668238, 668239, 668240, 668241, 817203, 817204, 817205, 817206, 817207, 817209, 817211, 817212, 817213, 817214, 817215, 817216, 817218, 817219, 817220, 817221, 817222, 817224, 817225, 817227, 817228, 817229, 817230, 817231, 817232, 1003409, 1003412, 1003415, 1003416, 1003418, 1044801, 1044802, 1044804, 1044809, 1044810, 1044811, 1044812, 1044814, 1044815, 1044822, 1044823, 1144426, 1144427, 1144428, 1144429, 1144430, 1144431, 1144432, 1144433, 1144434, 1144435, 1149668, 1149670, 1149671, 1149672, 1149673, 1149674, 1149675, 1149676, 1149677, 1149678, 1238018, 1238019, 1238022, 1238023, 1238024, 1238027, 1238028, 1238029, 1367886, 1367887, 1367888, 1367890, 1367891, 1367892, 1976731, 1976732, 1976734, 1976735, 2013177, 2013184, 2013185, 2283969, 2283970, 2283971, 2283972, 2283973, 2283974, 2283975, 2540140, 2540141, 2576239, 2576240, 2576242, 2576243, 2849311, 2849318, 2849320, 2849327, 2849328, 2849329; n. REF 106-28-60, GUDID 10885862014665, Serial Numbers: 669344, 669345, 669349, 669350, 669351, 669352, 669353, 669354, 669357, 669361, 669363, 1245687, 1245688, 1245689, 1245690, 1245693, 1245694, 1245695, 1245696, 1681724, 1681726, 1681727, 1681738, 2675692; o. REF 106-32-52, GUDID 10885862014726, Serial Numbers: 1030583, 1030585, 1030586, 1030588, 1030589, 1030590, 1030591, 1030592, 1348128, 1348129, 1348130, 1348131, 1348132, 1348134, 1348135, 1348136, 1348138, 1348139, 1348140, 1348141, 1348142, 1348143, 1348144, 1348145, 2097973, 2097974, 2097975, 2097976, 2149730, 2149731, 2149732, 2227914, 2227915, 2227916, 2227917, 2227918, 2227919, 2227920, 2227921, 2227922, 2227923, 2227926, 2227927, 2775290, 2775291, 2775292, 2775294, 2775295, 2775296, 2775297, 2775298, 2821141, 2821142, 2821144, 3594515, 3594517, 3594518, 3594519, 3667218, 3667219, 3695200, 4040041, 4571690, 4571691, 4607448, 4676840, 4706420, 4706421, 4732545, 4876519, 4876520, 4876521, 4876522, 4876523; p. REF 106-32-54, GUDID 10885862014733, Serial Numbers: 613294, 613297, 1301726, 1301727, 1301728, 1301730, 1301732, 1301733, 1301735, 1301736, 1301738, 1301739, 1301740, 1301741, 1301742, 1516738, 1516739, 1516741, 2257874, 2257875, 2257876, 2257877, 2314464, 2314465, 2314466, 2314467, 2314468, 2314469, 2314470, 2314471, 2314472, 2576244, 2778578, 2953225, 2953228, 3567915, 3964756, 4819662, 4819663, 4819664, 5165716, 5165718, 5165720; q. REF 106-32-56, GUDID 10885862014740, Serial Numbers: 613355, 613360, 613362, 1330058, 1330059, 1330060, 1330061, 1330062, 1339856, 1339857, 1339858, 1339861, 1339862, 1339863, 1339864, 1339866, 1339870, 1339871, 2277748, 2277749, 2277752, 2277753, 2821145, 2975331, 2975332; r. REF 106-32-58, GUDID 10885862014757, Serial Numbers: 624481, 1330631, 1330633, 1330634, 1339800, 1339801, 1339802, 1339803, 1339806, 1339809, 1339811, 1339813, 1339814, 2275886, 2630882, 2630883, 2675694, 2977092, 3770017, 3770018, 4016710, 4190635, 4190636, 5772709, 5772710, 5772712; s. REF 106-32-60, GUDID 10885862014764, Serial Numbers: 636606, 636607, 1332762, 1332763, 1332764, 1332765, 1332766, 1339977, 1339982, 1339983, 1339986, 1339987, 1339991, 2675700, 2675703, 3783796, 3964802, 4056149, 4413322, 4413325, 4413327, 4413329.

510(k) numbers

["K963313"]

PMA numbers

not on file

Product code

JDI

Firm FEI

1038671

Firm city

Gainesville

Firm state

FL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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