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U.S. Department of Health and Human Services

Class 2 Device Recall RECLAIM DISTAL TAPERED

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 Class 2 Device Recall RECLAIM DISTAL TAPEREDsee related information
Date Initiated by FirmJune 03, 2014
Date PostedJuly 21, 2014
Recall Status1 Terminated 3 on May 17, 2017
Recall NumberZ-2084-2014
Recall Event ID 68440
510(K)NumberK102080 
Product Classification Prosthesis, hip, semi-constrained (metal uncemented acetabular component) - Product Code KWA
ProductRECLAIM 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.
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.
Recalling Firm/
Manufacturer
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information ContactTia L. Holmes-Johnson
574-267-8143
Manufacturer Reason
for Recall
The product can be difficult to remove from the Distal Stem both out of the package and after proximal reaming.
FDA Determined
Cause 2
Device Design
ActionDePuy 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 in Commerce3,623
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KWA
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