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Recall Observatory FDA recall evidence

Device product

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.

Z-2084-2014

June 03, 2014

Class II

Product summary

Firm
DePuy Orthopaedics, Inc.
Event
Event 68440
Status
Terminated
Classification
Class II
Quantity
3,623
Official record key
device-enforcement:Z-2084-2014

Official wording

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

Code information: Product # 197614140; 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; Lot # 290958, 290959, 290960, 310940, 310941, 310942, 310947, 310948, 327468, 327469, 327475, 327477, 327478, 327480, 365792, 365793, 365794, 365795, 365796 & 365797. Product # 197615140; 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; Lot # 290964, 290966, 290967, 290969, 311800, 311802, 311804, 311806, 311808, 323743, 323744, 323746, 323748, 323750, 323754, 387702, 387703, 387704, 387705 & 387706. Product # 197616140; 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; 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; 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; Lot # 310403, 310949, 310950, 310951, 310952, 310953, 365800, 365806, 365808, 365810, 365811, 388879, 388883, 388885, 388888, 388891 & 388895. Product # 197618140; 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; 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; 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; 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; 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; Lot # 274964, 274965, 274966, 274976, 274977, 274978, 274979, 275004, 275006, 275007, 275009, 367589, 367590, 367591, 367592 & 367593. Product # 197621140; 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; Lot # 275013, 275014, 275015, 275018, 275019, 275021, 275022, 368544, 368548, 368549, 368550, 368551, 368632, 399737, 399738, 399739, 399740 & 399741.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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