CLASS II Device recall · Reported 30 Jul 2014 · FDA Enforcement Report

Reclaim Distal Tapered, Angled Distal Stem, various sizes recalled

DePuy Orthopaedics is recalling Reclaim Distal Tapered, Angled Distal Stem, various sizes, distributed in 49 states. The recall was initiated on 3 Jun 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct # 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.

Quantity recalled10,467 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2083-2014
FDA event ID: 68440
Recalling firm: DePuy Orthopaedics, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 3 Jun 2014
FDA classified: 20 Jul 2014
Reported: 30 Jul 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Hip & Knee Implants

Timeline

3 Jun 2014	Recall initiated by company
20 Jul 2014	Classified by FDA	+47 days
30 Jul 2014	Published in enforcement report	+10 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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.

Where it was distributed

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.

Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 68440

Reported	Class	Recall	Company	Reason	Where
30 Jul 2014	CLASS II	Reclaim Taper Protector Sleeve recalled by DePuy Orthopaedics	DePuy Orthopaedics	Packaging Defects	49 states
30 Jul 2014	CLASS II	Reclaim Distal Tapered Distal Stem, various sizes recalled	DePuy Orthopaedics	Packaging Defects	49 states

More recalls from DePuy Orthopaedics

All 153

Reported	Class	Recall	Company	Reason	Where
10 Apr 2024Device	CLASS II	Attune Affixium Cementless Fixed Bearing Knee recalled	DePuy Orthopaedics	Labeling Errors	Nationwide
29 Mar 2023Device	CLASS II	Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 recalled	DePuy Orthopaedics	Other	Nationwide
29 Mar 2023Device	CLASS II	Attune Revision Limb Preservation System (LPS) Tibial Insert XSM recalled	DePuy Orthopaedics	Other	Nationwide
29 Mar 2023Device	CLASS II	Attune Revision Limb Preservation System (LPS) Tibial Insert XSM recalled	DePuy Orthopaedics	Other	Nationwide
29 Mar 2023Device	CLASS II	Attune Revision Limb Preservation System (LPS) Tibial Insert SM recalled	DePuy Orthopaedics	Other	Nationwide

Other Hip & Knee Implants recalls

All 3,097

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
26 Aug 2026Device	CLASS II	Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation	Kico Knee Innovation	Device Malfunction	19 states
26 Aug 2026Device	CLASS II	Veritas Standard Reverse Total Shoulder Veritas Standard recalled	restor3d	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled	Waldemar Link GmbH & Co. KG (Mfg Site)	Other	IN
12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide