Reported Jul 30, 2014 · Terminated

RECLAIM DISTAL TAPERED Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic…

DePuy Orthopaedics, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: DePuy Orthopaedics, Inc. · 700 Orthopaedic Dr · Warsaw, IN · 46582-3994

Is this the product you have?

RECLAIM DISTAL TAPERED 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.

Lot codes and dates: 16 of 16 products
Products covered by this recall
# Product as published
1 Lot # 107310, 107311, 107313, 107314, 107315, 136244, 136247, 136251, 136252, 136256, 136257, 136262, 136268, 136271, 136276, 136286, 196221, 196222, 196225, 225871, 225872, 225873, 228185, 228187, 228188, 235886, 235887, 240634, 240635, 246147, 246179, 254812, 254814, 260373, 260374, 264629, 264630, 281910, 281911, 281912, 281915, 288356, 288359, 288361, 288363, 442821, 451586, 452549, 453409, 455523, 455524, 456513, 456514, 456515, 457650 & 457651. Product # 197614190
2 Lot # 290958, 290959, 290960, 310940, 310941, 310942, 310947, 310948, 327468, 327469, 327475, 327477, 327478, 327480, 365792, 365793, 365794, 365795, 365796 & 365797. Product # 197615140
3 Lot # 107320, 107323, 107325, 107328, 107330, 107331, 136369, 136370, 136371, 136372, 136373, 136374, 136375, 136376, 136377, 136377A, 136378, 136380, 136381, 196227, 196228, 225874, 225875, 225876, 228196, 228197, 228198, 231202, 235888, 235890, 239254, 239255, 251499, 251500, 251502, 251504, 254817, 254818, 260375, 260377, 264633, 264638, 383749, 393633, 405087, 420828, 421141, 432535, 442823, 451846, 457652, 465564, 465565, 480737, 482786, 491057, 497256, 503931, 518456, 523799 & 526931. Product # 197615190
4 Lot # 290964, 290966, 290967, 290969, 311800, 311802, 311804, 311806, 311808, 323743, 323744, 323746, 323748, 323750, 323754, 387702, 387703, 387704, 387705 & 387706. Product # 197616140
5 Lot # 136419, 136420, 136454, 136455, 136456, 136457, 136459, 136460, 136467, 136478, 136480, 136481, 225877, 225878, 225879, 225880, 225881, 228126, 228127, 228128, 228129, 228130, 239256, 239257, 240636, 246148, 246149, 246180, 254822, 254825, 260378, 260379, 264639, 264640, 264641, 281918, 281922, 281923, 281924, 288366, 288367, 288368, 288370, 288374, 405088, 405089, 415495, 418748, 421512, 422731, 461416, 461417, 461418, 461419, 461420, 461421, 466522, 466523, 466524, 466525, 472003, 475333, 482787, 493055, 499964, 503926, 516019, 518462, 520979, 523800, 526933 & FH1PH1. Product # 197616190
6 Lot # 290971, 290972, 290975, 290977, 314437, 314438, 314439, 314451, 314454, 331071, 331072, 331073, 331074, 331076, 331077, 331081, 331082, 331085, 331086, 331087, 331088 & 331089. Product # 197617140
7 Lot # 107333, 107334, 107336, 107338, 107339, 107340, 136561, 136564, 136565, 136566, 136568, 136569, 136574, 136575, 162577, 162578, 162580, 162581, 162582, 163061, 163062, 163063, 228199, 228200, 228202, 235892, 235893, 239258, 239259, 239261, 246151, 246152, 246181, 251506, 251507, 251509, 260380, 260381, 260382, 264642, 264643, 281926, 281927, 316391, 316394, 316396, 316399, 339767, 339768, 339769, 339770, 339771, 339773, 339774, 393634, 400314, 405090, 415496, 415497, 421921, 432022, 432537, 438468, 442824, 451587, 452550, 453410, 455526, 457653, 465566, 469296, 472012, 480807, 482788, 497257, 503930, 520980, 520981, 520982 & 523801. Product # 197617190
8 Lot # 310403, 310949, 310950, 310951, 310952, 310953, 365800, 365806, 365808, 365810, 365811, 388879, 388883, 388885, 388888, 388891 & 388895. Product # 197618140
9 Lot # 136576, 136577, 136578, 136579, 136580, 136581, 136583, 136584, 136585, 136587, 136588, 136589, 163065, 163066, 163068, 163069, 163070, 163071, 235894, 235927, 239264, 239297, 239301, 246154, 246182, 251511, 251512, 254826, 254827, 281928, 281929, 281931, 281932, 288706, 288707, 288708, 288709, 288710, 288711, 383750, 405091, 405092, 415498, 422252, 422733, 432540, 438059, 445826, 451847, 453411, 457654, 462108, 465567, 475332, 480808, 493056, 499966, 516009, 518464, 523802, 526934, FF8M1A, FF8M2A & FF8M3A. Product # 197618190
10 Lot # 294652, 294654, 294658, 294659, 323871, 323873, 323874, 323875, 323876, 323877, 323878, 323880, 323882, 323884, 323886, 323888, 323890, 365971, 365979, 365983, 365988 & 365991. Product # 197619140
11 Lot # 138296, 138299, 138300, 138302, 138303, 138305, 138307, 138309, 138310, 138313, 138316, 163073, 163074, 163075, 163076, 163077, 163350, 163353, 228205, 228207, 235928, 235930, 239303, 239304, 239306, 246156, 246183, 251513, 251516, 254829, 254830, 260383, 260384, 264644, 264645, 281934, 281935, 281936, 281938, 281939, 288375, 288377, 288380, 288382, 288384, 445827, 451848, 453412, 453413, 455527, 482789, 482790, 493057, 494062 & FF9NAA. Product # 197619190
12 Lot # 290981, 290982, 290985, 290986, 290990, 290991, 290992, 290995, 290997, 290999, 291000, 311325, 323893, 323895, 323897, 323899, 323901, 323902, 323904, 327356, 327358, 327359, 327360, 327361, 327362, 327363 & 327364. Product # 197620140
13 Lot # 138319, 138321, 138322, 138323, 138331, 196229, 196231, 196232, 225882, 225883, 228131, 228132, 228134, 228135, 228140, 239320, 239322, 239328, 246187, 246190, 260386, 260394, 264812, 264813, 281940, 281942, 281943, 281945, 281946, 288387, 288390, 288392, 288394, 288401, 493058, 494063, FF9NLA & FF9NMA. Product # 197620190
14 Lot # 274964, 274965, 274966, 274976, 274977, 274978, 274979, 275004, 275006, 275007, 275009, 367589, 367590, 367591, 367592 & 367593. Product # 197621140
15 Lot # 138343, 138346, 138347, 138349, 138350, 138351, 138352, 138353, 138354, 138355, 138356, 196240, 196242, 225884, 225885, 228143, 228145, 228146, 228147, 228148, 239335, 239337, 239340, 240637, 251517, 251518, 254831, 254836, 264814, 264815, 281954, 281955, 281956, 281957, 281958, 288419, 288420, 288423, 288426, 288427, 288428 & FG211A. Product # 197621190
16 Lot # 275013, 275014, 275015, 275018, 275019, 275021, 275022, 368544, 368548, 368549, 368550, 368551, 368632, 399737, 399738, 399739, 399740 & 399741.
Amount recalled: 3,623

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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By hazard

Medical device recalls

Other recalls from DePuy Orthopaedics, Inc.

53 in total.

Where it was distributed

All recall categories · Browse the whole archive

#	Product as published
1	Lot # 107310, 107311, 107313, 107314, 107315, 136244, 136247, 136251, 136252, 136256, 136257, 136262, 136268, 136271, 136276, 136286, 196221, 196222, 196225, 225871, 225872, 225873, 228185, 228187, 228188, 235886, 235887, 240634, 240635, 246147, 246179, 254812, 254814, 260373, 260374, 264629, 264630, 281910, 281911, 281912, 281915, 288356, 288359, 288361, 288363, 442821, 451586, 452549, 453409, 455523, 455524, 456513, 456514, 456515, 457650 & 457651. Product # 197614190
2	Lot # 290958, 290959, 290960, 310940, 310941, 310942, 310947, 310948, 327468, 327469, 327475, 327477, 327478, 327480, 365792, 365793, 365794, 365795, 365796 & 365797. Product # 197615140
3	Lot # 107320, 107323, 107325, 107328, 107330, 107331, 136369, 136370, 136371, 136372, 136373, 136374, 136375, 136376, 136377, 136377A, 136378, 136380, 136381, 196227, 196228, 225874, 225875, 225876, 228196, 228197, 228198, 231202, 235888, 235890, 239254, 239255, 251499, 251500, 251502, 251504, 254817, 254818, 260375, 260377, 264633, 264638, 383749, 393633, 405087, 420828, 421141, 432535, 442823, 451846, 457652, 465564, 465565, 480737, 482786, 491057, 497256, 503931, 518456, 523799 & 526931. Product # 197615190
4	Lot # 290964, 290966, 290967, 290969, 311800, 311802, 311804, 311806, 311808, 323743, 323744, 323746, 323748, 323750, 323754, 387702, 387703, 387704, 387705 & 387706. Product # 197616140
5	Lot # 136419, 136420, 136454, 136455, 136456, 136457, 136459, 136460, 136467, 136478, 136480, 136481, 225877, 225878, 225879, 225880, 225881, 228126, 228127, 228128, 228129, 228130, 239256, 239257, 240636, 246148, 246149, 246180, 254822, 254825, 260378, 260379, 264639, 264640, 264641, 281918, 281922, 281923, 281924, 288366, 288367, 288368, 288370, 288374, 405088, 405089, 415495, 418748, 421512, 422731, 461416, 461417, 461418, 461419, 461420, 461421, 466522, 466523, 466524, 466525, 472003, 475333, 482787, 493055, 499964, 503926, 516019, 518462, 520979, 523800, 526933 & FH1PH1. Product # 197616190
6	Lot # 290971, 290972, 290975, 290977, 314437, 314438, 314439, 314451, 314454, 331071, 331072, 331073, 331074, 331076, 331077, 331081, 331082, 331085, 331086, 331087, 331088 & 331089. Product # 197617140
7	Lot # 107333, 107334, 107336, 107338, 107339, 107340, 136561, 136564, 136565, 136566, 136568, 136569, 136574, 136575, 162577, 162578, 162580, 162581, 162582, 163061, 163062, 163063, 228199, 228200, 228202, 235892, 235893, 239258, 239259, 239261, 246151, 246152, 246181, 251506, 251507, 251509, 260380, 260381, 260382, 264642, 264643, 281926, 281927, 316391, 316394, 316396, 316399, 339767, 339768, 339769, 339770, 339771, 339773, 339774, 393634, 400314, 405090, 415496, 415497, 421921, 432022, 432537, 438468, 442824, 451587, 452550, 453410, 455526, 457653, 465566, 469296, 472012, 480807, 482788, 497257, 503930, 520980, 520981, 520982 & 523801. Product # 197617190
8	Lot # 310403, 310949, 310950, 310951, 310952, 310953, 365800, 365806, 365808, 365810, 365811, 388879, 388883, 388885, 388888, 388891 & 388895. Product # 197618140
9	Lot # 136576, 136577, 136578, 136579, 136580, 136581, 136583, 136584, 136585, 136587, 136588, 136589, 163065, 163066, 163068, 163069, 163070, 163071, 235894, 235927, 239264, 239297, 239301, 246154, 246182, 251511, 251512, 254826, 254827, 281928, 281929, 281931, 281932, 288706, 288707, 288708, 288709, 288710, 288711, 383750, 405091, 405092, 415498, 422252, 422733, 432540, 438059, 445826, 451847, 453411, 457654, 462108, 465567, 475332, 480808, 493056, 499966, 516009, 518464, 523802, 526934, FF8M1A, FF8M2A & FF8M3A. Product # 197618190
10	Lot # 294652, 294654, 294658, 294659, 323871, 323873, 323874, 323875, 323876, 323877, 323878, 323880, 323882, 323884, 323886, 323888, 323890, 365971, 365979, 365983, 365988 & 365991. Product # 197619140
11	Lot # 138296, 138299, 138300, 138302, 138303, 138305, 138307, 138309, 138310, 138313, 138316, 163073, 163074, 163075, 163076, 163077, 163350, 163353, 228205, 228207, 235928, 235930, 239303, 239304, 239306, 246156, 246183, 251513, 251516, 254829, 254830, 260383, 260384, 264644, 264645, 281934, 281935, 281936, 281938, 281939, 288375, 288377, 288380, 288382, 288384, 445827, 451848, 453412, 453413, 455527, 482789, 482790, 493057, 494062 & FF9NAA. Product # 197619190
12	Lot # 290981, 290982, 290985, 290986, 290990, 290991, 290992, 290995, 290997, 290999, 291000, 311325, 323893, 323895, 323897, 323899, 323901, 323902, 323904, 327356, 327358, 327359, 327360, 327361, 327362, 327363 & 327364. Product # 197620140
13	Lot # 138319, 138321, 138322, 138323, 138331, 196229, 196231, 196232, 225882, 225883, 228131, 228132, 228134, 228135, 228140, 239320, 239322, 239328, 246187, 246190, 260386, 260394, 264812, 264813, 281940, 281942, 281943, 281945, 281946, 288387, 288390, 288392, 288394, 288401, 493058, 494063, FF9NLA & FF9NMA. Product # 197620190
14	Lot # 274964, 274965, 274966, 274976, 274977, 274978, 274979, 275004, 275006, 275007, 275009, 367589, 367590, 367591, 367592 & 367593. Product # 197621140
15	Lot # 138343, 138346, 138347, 138349, 138350, 138351, 138352, 138353, 138354, 138355, 138356, 196240, 196242, 225884, 225885, 228143, 228145, 228146, 228147, 228148, 239335, 239337, 239340, 240637, 251517, 251518, 254831, 254836, 264814, 264815, 281954, 281955, 281956, 281957, 281958, 288419, 288420, 288423, 288426, 288427, 288428 & FG211A. Product # 197621190
16	Lot # 275013, 275014, 275015, 275018, 275019, 275021, 275022, 368544, 368548, 368549, 368550, 368551, 368632, 399737, 399738, 399739, 399740 & 399741.