DePuy Orthopaedics, Inc.: RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

Recall number

Z-2083-2014

Recalling firm

DePuy Orthopaedics, Inc.

Product

RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

Status

Terminated

Initiated

2014-06-03

Posted

2014-07-21

Terminated

2017-05-17

Reason

The product can be difficult to remove from the Distal Stem both out of the package and after proximal reaming.

Root cause

Device Design

Action

DePuy Synthes sent an Urgent Information - Device Correction Notice letter dated June 24, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: 1. Immediate Remedy: Discard the RECLAIM Taper Sleeve Protector instrument before stem implantation. 2. Changes to the literature and IFU: Documents are revised as follows: " RECLAIM Revision Hip Systems Surgical Technique # DSUS/JRC/0614/0200 pages 11, 12, 13, 16, 30, 34, 35 (figure numbering from pages 11 to 27 were also revised): Removed information regarding taper sleeve protector. " RECLAIM Revision Hip Systems Surgical Technique FAQ # DSUS/JRC/0614/0202 pages 1 and 2: Removed information regarding taper sleeve protector. " RECLAIM Revision Hip Systems IFU #090200799 REV E Page 5: Verbiage will be revised and implemented as soon as possible, depending on regulatory approvals. 3. Change: The company consulted with design surgeons and developed a strategy to eliminate the taper sleeve protector from the system. As a result of removing the taper sleeve protector, the company is evaluating whether there is a need for a protective component to be used during the distribution Customers with questions were instructed to call 574-371-4917. For questions regarding this recall call 574-371-4577.

Quantity

10,467 units

Distribution

Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI & WV and Internationally to AUSTRALIA, AUSTRIA, CANADA, CHILE, CHINA, CZECH REPUBLIC, DENMARK, FRANCE, GERMANY, IBERIA, IRELAND, ISRAEL, ITALY, NEW ZEALAND, NORWAY, POLAND, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWITZERLAND & UK.

Lot, serial or model codes

Product # 197714190; Lot # 107342, 107343, 107346, 107347, 138357, 138358, 138359, 138360, 138361, 138362, 138363, 163354, 163356, 163357, 190780, 190783, 190784, 211757, 211758, 225886, 225887, 228150, 228153, 231204, 235931, 235932, 235935, 246196, 246197, 251519, 251520, 254838, 254839, 264816, 264817, 282507, 282509, 282511, 282512, 288712, 288713, 288714, 288715, 288716 & 288717.  Product # 197715190; Lot # 107603, 107605, 107607, 107610, 107612, 138364, 138365, 138366, 138367, 138368, 138369, 138370, 138373, 138374, 163358, 211759, 211760, 211761, 225888, 225889, 228160, 228162, 228164, 228165, 228166, 235939, 235941, 239345, 254840, 254842, 260398, 260401, 264818, 264819, 282513, 282514, 282516, 288718, 288719, 288720, 288721, 288722, 288723 & 288725.  Product # 197716190; Lot # 136503, 136515, 136517, 136518, 136519, 136521, 136522, 136524, 136525, 136535, 190767, 190769, 190772, 190775, 190776, 196006, 196007, 196008, 196009, 226259, 226260, 226261, 228211, 228212, 228214, 231210, 235942, 235944, 239348, 246198, 246199, 246200, 260404, 260406, 264820, 264821, 264822, 282517, 282518, 282519, 288727, 288729, 288731, 288734 & 288736.  Product # 197716240; Lot # 107616, 107618, 107620, 107623, 150282, 150286, 150291, 150292, 151020, 151022, 151031, 151032, 151051, 196002, 196004, 196005, 211768, 211769, 226262, 226263, 231181, 231182, 231183, 231184, 231186, 231187, 231189, 239350, 246201, 246202, 260407, 260408, 264823, 264824, 282520, 282521, 282522 & 282524.  Product # 197717190; Lot # 107635, 107639, 107641, 107642, 107646, 150312, 150313, 150314, 150315, 150317, 150318, 151060, 151061, 151065, 151066, 151068, 152323, 152324, 152325, 152328, 152330, 152332, 152333, 231205, 231211, 239352, 239355, 239359, 246203, 246204, 260409, 260410, 264825, 264826, 264828, 316404, 316405, 316406, 316408, 372515, 415503, 422253, 428484, 451588, 452551, 452552, 453414, 453415, 454332, 455528, 493028, 493029, 493030 & 499967.  Product # 197717240; Lot # 110419, 110423, 110424, 110425, 110426, 152336, 152337, 152338, 152740, 152741, 152745, 152746, 152750, 152752, 152755, 211770, 211771, 211772, 226264, 231196, 231197, 231198, 231199, 231201, 239360, 239361, 239362, 245262, 245265, 260411, 260415, 264829 & 264830.  Product # 197718190; Lot #, 152758, 152763, 152768, 152769, 153106, 153107, 153108, 153109, 153110, 153111, 153112, 153113, 153114, 153115, 153116, 153117, 153118, 153119, 228219, 228222, 228223, 231212, 235945, 240639, 240641, 240642, 246238, 246239 , 251521, 251522, 260416, 260420, 265279, 265281, 265282, 339777, 339785, 339798, 339801, 339803, 339817, 469297, 493032, 499969, 503929 & 523803.  Product # 197718240; Lot # 153612, 153615, 153616, 153617, 153619, 153620, 153621, 153623, 153624, 153625, 153627, 153628, 153629, 153630, 154207, 154208, 154209, 231207, 231208, 231209, 231213, 231214, 231215, 246241, 246242, 260425, 260427, 265283, 265284, 65285 & FF9RSA.  Product # 197718290; Lot # 343075, 352965, 352966, 352967, 371864, 371868, 371884, 371888 & 371889.  Product # 197719190; Lot # 154215, 154216, 154218, 154219, 154223, 154224, 154227, 154228, 154231, 154232, 154235, 154236, 154903, 154905, 154910, 154911, 154914, 154915, 154917, 154918, 154919, 154920, 154921, 154922, 228216, 246243, 246244, 260430, 260432, 265286, 265288, 265289, 265290, 339819, 339821, 339823, 339828, 339832, 339833, 453416, 454333, 454334, 457064, 457067, 457068 & 503927.  Product # 197719240; Lot # 154923, 154924, 154925, 155258, 155259, 155261, 155262, 155263, 155264, 155265, 155266, 155267, 155268, 155269, 155270, 155271, 155272, 155273, 155274, 155665, 155667, 155668, 260435, 260438, 265292, 265293, 339834, 339835, 339836, 339837, 339853 & 339854.  Product # 197719290; Lot # 343076, 352968, 352969, 371890, 371891, 371892 & 371893.  Product # 197720190; Lot # 155671, 155674, 155675, 155679, 155680 , 155682, 155684, 155689, 155691, 155697, 155698, 155703, 155704, 157780, 157782, 157783, 157786, 157787, 157791, 157792, 157793, 157796, 157800, 240654, 246246, 246247, 246248, 260442, 260448, 265294, 265295, 265296, 265297, 457655, 460826 , 475331, 520983 & 523804.  Product # 197720240; Lot # 110427, 110428, 110429, 110430, 110431, 157811, 157812, 157826, 157827, 157833, 158335, 158338, 158339, 158346, 158347, 158353, 158354, 158361, 158362, 158363, 231216, 231217, 231218, 231219, 236967, 236969, 240655, 240656, 251523, 251524, 254845 &, 254848.  Product # 197720290 Lot # 343077, 352970, 371899, 371900, 371901, 371902, 371903, 371905 & 371906.  Product # 197721190; Lot # 158364, 158365, 158366, 158368, 158369, 158859, 158860, 158862, 158863, 158865, 158866, 158870, 158871, 158874, 158875, 158879, 158881, 158884, 158885, 235947, 235948, 240657, 240658, 251527, 251528, 260452, 260453, 260456, 265298, 265299, 415504, 446635, 497258 & FG2XWA.  Product # 197721240; Lot # 159674, 159676, 159682, 159683, 159686, 159687, 159689, 159692, 159697, 159699, 159702, 159704, 159707, 159708, 159713 , 226266, 231220, 231221, 231222, 231223, 235950, 240659, 251530, 251531, 260458, 260459, 260460, 265300 , 265301 & E72JPA. Product # 197721290; Lot # 343078, 352971, 352972, 352973, 352974, 371907, 371908, 371909, 371910 & 371911.  Product # 197722190; Lot # 107658, 107660, 107662, 107666, 107670, 160042, 160043, 160045, 160046, 160049, 160051, 160055, 160056, 160059, 160060, 160062, 160063, 160065, 226267, 226269, 228167, 228168, 228170, 228172, 228175, 240660, 240661, 240662, 251532, 251534, 254851, 254853, 265660, 265661, 339857, 339861, 339864, 339868, 339875, 339880 & E72KNA.  Product # 197722240; Lot # 108360, 108361, 108362, 160067, 160069, 160070, 183484, 190402, 190403, 190407, 190408, 190409, 192784, 192792, 192795, 210716, 210718, 210719, 226270, 226271, 226272, 231224, 231225, 231226, 238694, 238695, 238696, 246249, 246250, 254854, 254855, 260462 & 260463.  Product # 197723190; Lot # 108363, 136546 , 136548, 136550, 136551, 136552, 136553, 160701, 160702, 160703, 160704, 160705, 160706, 195997, 195998, 195999, 230474, 230475, 230477, 230478, 230480, 230481, 230482, 231227, 235951, 240663, 240664, 240666, 251535, 251536, 260466, 260469, 265662, 265663, 469298 & 499968.  Product # 197723240; Lot # 108368, 108369, 108370, 183408, 183409, 183413, 183415, 190412, 190418, 190419, 190420, 190423, 190764, 192804, 192805, 192809, 192810, 210710, 226273, 226276, 226277, 231228, 231229, 231230, 235953, 240673, 240674, 251537, 251538, 254856 & 254857.  Product # 197723290; Lot # 318199, 318201, 318204, 318206, 318208, 318210, 323905, 323906, 323907, 323913 & 323918.  Product # 197724190; Lot # 108371, 108372, 108373, 108374, 108375, 108376, 160708, 160711, 160712, 160714, 160715, 160717, 160718, 160719, 160720, 161365, 161366, 161371, 226278, 226279, 228177, 228178, 228180, 228181, 228183, 235955, 240675, 240676, 251539, 251540, 260470, 260472, 265665 & 265666.  Product # 197724240; Lot # 108867, 108871, 108876, 108877, 108880, 108884, 183417, 192257, 192259, 192261, 192264, 201140, 202531, 202532, 202533, 202534, 202535, 226285, 226286, 226287, 231231, 231232, 231233, 231234, 235956, 240677, 240678, 246251, 246252, 254858, 254859, 260475, 260477, 260479 & E81LPB.  Product # 197725190; Lot # 108888, 108889, 108893, 108895, 108896, 161376, 161469, 161471, 161475, 161476, 161477, 161478, 161481, 161482, 161483, 161484, 161488, 210704, 226290, 226292, 226293, 231235, 231236, 231237, 235958, 240679, 240680, 240681, 251544, 251545, 260481, 260486.  Product # 197725240; Lot # 108900, 108905, 108907, 108911, 108912, 191549, 191551, 192267, 192268, 192771, 192775, 192778, 210672, 210686, 210687, 210693, 210694, 210700, 226294, 226295, 231238, 231239, 231240, 235959, 245271, 251547, 251548, 251549, 254803, 254805, 254810 & 254811.  Product # 197725290; Lot # 343079, 352975, 352976, 352977, 430904, 430905 & 430906.  Product # 197726190; Lot # 108916, 108920, 108923, 108926, 108930, 161924, 161925, 161926, 161928, 161929, 161930, 161931, 161933, 161935, 161937, 161938, 161939, 226297, 226301, 226302, 226304, 231241, 231242, 231243, 231244, 245273, 251551, 251552, 251553, 260490, 260496, 265667 & 265668.  Product # 197726240; Lot # 110393, 110395, 110399, 110400, 110402, 191533, 191535, 191537, 191539, 192247, 192251, 192253, 192255, 226305, 226306, 226307, 226308, 226309, 229204, 229205, 229207, 229208, 229209, 231245, 231246, 246253, 246254, 254860, 254861, 265672 & 265675.  Product # 197727190; Lot # 110404, 110405, 110406, 110407, 110409, 161944, 161947, 161948, 162555, 162557, 162558, 162560, 162561, 162565, 162566, 162572, 162573, 226310, 226311, 231247, 231248, 231249, 231250, 235960, 245274, 254862, 254863, 254864, 260503, 260504, 260508, 277152, 277153, 277155, 277158, 277161 & 277163.  Product # 197727240; Lot # 110411, 110412, 110414, 110414A, 110416, 110418, 191503, 191509, 191512, 191514, 201136, 201137, 226312, 226313, 226314, 226315, 226316, 231251, 231252, 231253, 231254, 245277, 254865, 260513, 260515, 260516, 352978, 352979, 430907, 430908 & 430909.  Product # 197729190; Lot # 343081, 353019, 353020, 353022 & 353023.  Product # 197729240; Lot # 343082, 353091, 353092, 353093, 353095 & 353099.  Product # 197729290; Lot # 343083, 352980, 352981, 352982, 352983 & 352984.  Product # 197731190; Lot # 343084, 353103, 353105, 353109, 353110, 353111 & 353113.  Product # 197731240; Lot # 343085, 353115, 353118, 353122, 353123 & 353126.  Product # 197731290; Lot # 331096.

510(k) numbers

["K102080"]

PMA numbers

not on file

Product code

KWA

Firm FEI

1818910

Firm city

Warsaw

Firm state

IN

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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