Z-2084-2014Class II

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

Name: Z-2084-2014 RECLAIM DISTAL TAPERED Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System...
Creator: DePuy Orthopaedics, Inc.
Published: 2014-06-03
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2014-06-03 / Terminated / root cause: design

FDA source

DePuy Orthopaedics, Inc. began a recall of RECLAIM DISTAL TAPERED Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure... on 2014-06-03. FDA classified it as Class II and gives the reason as "The product can be difficult to remove from the Distal Stem both out of the package and after proximal reaming". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2084-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-03
Posted: 2014-07-21
Terminated: 2017-05-17
Recalling firm: Depuy Orthopaedics Inc.
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.
Product code: KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Reason for recall: The product can be difficult to remove from the Distal Stem both out of the package and after proximal reaming.
Root cause tag: design
FDA root cause: Device Design
Action: DePuy 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 commerce: 3,623
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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2084-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2082-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-30	2014-07-20
Z-2083-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-30	2014-07-20
Z-2084-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-30	2014-07-20

Product code KWA

K102080Class IIDepuy Reclaim Revision Hip SystemDepuy(Ireland) / cleared 2010-11-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)