Exactech, Inc.: Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21, SZ. N; d) 100-22-22, SZ. P; e) 100-22-23, SZ. R; f) 100-22-24, SZ. S; g) 100-22-25, SZ. T

Recall number

Z-2236-2024

Recalling firm

Exactech, Inc.

Product

Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21, SZ. N; d) 100-22-22, SZ. P; e) 100-22-23, SZ. R; f) 100-22-24, SZ. S; g) 100-22-25, SZ. T

Status

Open, Classified

Initiated

2024-04-26

Posted

2024-06-28

Terminated

not on file

Reason

The AcuMatch L-Series 22mm Inner Diameter Bipolar Hip Liner lots were packaged without the specified ethylene vinyl alcohol (EVOH) layer. Between 2004 and August 2021, our packaging process utilized two different types of packaging materials: 1) Low Density Polyethylene (LDPE), Nylon, and EVOH, or 2) LDPE and Nylon without EVOH.

Root cause

Other

Action

Exactech issued an UREGNT VOLUNTARY MEDICAL DEVICE RECALL notice to its sales representatives on 04/26/2024 via email. The notice explained the issue, clinical impact (risk), and requested the following: Actions to be Taken: " Review this notification thoroughly. " Immediately discontinue use and quarantine any affected product. " Distribute this Recall Letter to all the surgeons who have implanted the affected devices. " Send all affected product back to Exactech as outlined in the attached Recall Confirmation Form .

Quantity

589 units

Distribution

Worldwide - US distribution in Puerto Rico and the countries of Great Britain, Japan.

Lot, serial or model codes

a) 100-22-19, UDI/DI 10885862009302, Lot Numbers: 2051878, 2051881, 2051883, 2051884, 2051897, 2051899, 2051904, 2051906, 2051901, 2583739, 2583740, 2583741, 2583742, 2583743, 2583744, 2583745, 2583746, 2583747, 2583748, 2583749, 2583750, 2583751, 2583752, 2583753, 2583754, 2583755, 2583756, 2583758, 2583763, 2583764, 2583765, 2583766, 2583767, 2583768, 2583771, 2583772, 2583773, 2583774, 2583775, 2583776, 2583777, 2583757, 2583759, 2583760, 2583761, 2583762, 2583769, 2583770, 4413099, 4413105, 4413093, 4413114, 4413100, 4413117, 4413116, 4413112, 6528255, 6528254, 6528269, 6528275, 6528264, 6528259, 6528267, 6528263, 6528257, 6528261, 6528270, 6528256, 2051882, 2051900, 4065533, 4082594, 4356568, 4356569, 4356570, 4356572, 4413101, 4413108, 4413113; b) 100-22-20, UDI/DI 10885862009319, Lot Numbers: 2966253, 2736353, 956428, 956429, 956430, 956431, 956432, 956433, 956434, 956435, 956439, 956440, 956441, 956442, 956443, 956448, 956447, 956426, 956437, 956438, 956444, 956446, 956450, 956427, 956445, 1766644, 1766645, 1766647, 1766648, 1766649, 1766651, 1766652, 1766653, 1766654, 1766662, 1766664, 1766665, 1766669, 1766670, 1766646, 1766650, 1766655, 1766656, 1766657, 1766658, 1766659, 1766660, 1766661, 1766663, 1766666, 1766667, 1766668, 1973677, 1973679, 1973680, 1973681, 1973682, 1973683, 1973684, 1973685, 1973686, 1973688, 1973690, 1973676, 1973678, 1973687, 1973691, 1973693, 1973674, 1973675, 1973689, 1973692, 2074521, 2106219, 2114000, 2114001, 2114002, 2114003, 2114004, 2114005, 2114006, 2114007, 2134272, 2134276, 2134277, 2134278, 2134279, 2134280, 2134273, 2134274, 2134275, 2134281, 2136981, 2136982, 2136983, 2136984, 2136985, 2136986, 2136987, 2136988, 2136989, 2136990, 2136991, 2136992, 2136993, 2136994, 2136995, 2136996, 2209987, 2209988, 2209989, 2209990, 2209991, 2251069, 2251073, 2251074, 2251075, 2251076, 2251077, 2251078, 2251079, 2251080, 2251082, 2251083, 2251084, 2251086, 2251087, 2251088, 2251089, 2251090, 2251091, 2251092, 2251093, 2251066, 2251067, 2251068, 2251070, 2251071, 2251072, 2251081, 2251085, 2254888, 2254889, 2254890, 2254891, 2254892, 2254893, 2254894, 2254895, 2254896, 2254897, 2254898, 2254899, 2254900, 2254901, 2254902, 2254903, 2254904, 2254905, 2254906, 2254907, 2254908, 2254909, 2254910, 2254911, 2254912, 2254913, 2254914, 2351931, 2351932, 2351933, 2351934, 2351935, 2351936, 2351937, 2351938, 2351939, 2351940, 2351941, 2351942, 2351943, 2351944, 2351945, 2351946, 2351947, 2351948, 2351949, 2351950, 2583935, 2583936, 2583937, 2583938, 2583939, 2583940, 2583941, 2583942, 2385507, 2385508, 2385509, 2385510, 2385511, 2385512, 2385513, 2385514, 2385515, 2385516, 2385517, 2385518, 2630904, 2630905, 2630906, 2630907, 2630908, 2630909, 2630910, 2630911, 2630912, 2630913, 2630914, 2630915, 2630916, 2630917, 2630918, 2630919, 2630920, 2736352, 2736355, 2736356, 2736357, 2736358, 2736359, 2736360, 2736361, 2736363, 2736364, 2736365, 2736366, 2736367, 2736369, 2736371, 2736373, 2736374, 2736375, 2736377, 2736378, 2736379, 2736381, 2736382, 2385519, 2962338, 2962339, 2962340, 2962341, 2962342, 2962343, 2962344, 2962345, 2966234, 2966235, 2966236, 2966237, 2966238, 2966239, 2966240, 2966242, 2966244, 2966246, 2966247, 2966248, 2966249, 2966250, 2966251, 2966252, 2966254, 2966255, 2966256, 2966257, 2966241, 2966243, 2966245, 3571556, 3571557, 3571558, 3571559, 3571560, 3571561, 3571562, 3571563, 3571564, 3571565, 3571566, 3571567, 3571568, 3571569, 3571570, 3571571, 3571572, 3571573, 3571574, 3571576, 3571579, 3571580, 3571582, 3571584, 3571585, 3571586, 3571589, 3571590, 3571591, 2736354, 2736362, 2736368, 2736370, 2736372, 2736376, 2736380, 3642893, 3684532, 3642894, 3684533, 3684526, 3571555, 3684523, 3571581, 3684527, 3571583, 3571575, 3571588, 3571587, 3744782, 3684537, 3684538, 3571577, 3571578, 3684524, 3731129, 3731133, 3684531, 3744784, 3744778, 3684525, 3705738, 3642895, 3684535, 3684528, 3684534, 3744779, 3744783, 3744781, 3684530, 3731131, 3731132, 3684529, 3705737, 3684536, 4264663, 3873634, 3744780, 3731130, 3705735, 4479481, 3873636, 4479480, 4264660, 3873635, 3873637, 4487182, 3873638, 4678963, 4678953, 4678967, 3705736, 4264662, 3873640, 4479482, 4479483, 4479485, 4678966, 4678965, 4678951, 4678955, 4678957, 4678947, 4678950, 4678970, 4678964, 4678960, 4678959, 4678958, 4678956, 4487181, 4479479, 4678972, 4678969, 4678954, 4678949, 4678961, 4678952, 4678968, 4678971, 4678962, 4264661, 5853133, 4479484, 4678948, 5853127, 5853140, 5853134, 5853129, 5853132, 5853137, 5853135, 5853142, 5853126, 5853136, 5853130, 5853131, 5853128, 5853139, 5853141; c) 100-22-21, UDI/DI 10885862009326, Lot Numbers: 953626, 953627, 953628, 953629, 953630, 953631, 953632, 953633, 953634, 953635, 953636, 953637, 953638, 953639, 953640, 953641, 953642, 953643, 953644, 953645, 953646, 953647, 953648, 953649, 953650, 956154, 956158, 956160, 956171, 956175; d) 100-22-22, UDI/DI 10885862009333, Lot Numbers: 955631, 955633, 955634, 955635, 955636, 955637, 955638, 955639, 955640, 955641, 955642, 955643, 955644, 955645, 955646, 955647, 955649, 955650, 955651, 955652, 955653, 955654, 955655, 955656, 955657, 955658, 955659, 955660, 955661, 955662, 955663, 955664, 955665, 955666, 955667, 955668, 955669, 955670, 955648, 955671; e) 100-22-23, UDI/DI 10885862009340, Lot Numbers: 956100, 956101, 956104, 956105, 956106, 956107, 956108, 956109, 956110, 956113; f) 100-22-24, UDI/DI 10885862009357, Lot Numbers: 956461, 956462, 956464, 956469, 956470, 956471, 956472, 956473, 956474, 956466; g) 100-22-25, UDI/DI 10885862009364, Lot Numbers:

510(k) numbers

K013211

PMA numbers

not on file

Product code

KWY

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 3e6df46828c1, published 2026-10-06

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