FDA Enforcement Class II Terminated

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: Z-2083-2014 · Reported July 30, 2014

Enforcement

Recall Number: Z-2083-2014
Event ID: 68440
Classification: Class II
Status: Terminated
Product Type: Devices
Firm: DePuy Orthopaedics, Inc.
Voluntary / Mandated: Voluntary: Firm initiated
Initial Notification: Letter
Report Date: July 30, 2014
Initiation Date: June 3, 2014
Classification Date: July 20, 2014
Termination Date: May 17, 2017
Address: 700 Orthopaedic Dr, Warsaw, IN, 46582-3994, United States

Description

Reason

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

Code Info

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.

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.

Quantity

10,467 units