Recall Z-2084-2014
DePuy Orthopaedics, Inc. · initiated June 3, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / 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 #…
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: Device Design
Action taken
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.
Details
- Recall number
- Z-2084-2014
- Initiated
- June 3, 2014
- Posted by FDA
- July 21, 2014
- Terminated
- May 17, 2017
- Product code
- KWA – Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
- Quantity
- 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…
- Recalling firm
- DePuy Orthopaedics, Inc., Warsaw, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2082-2014 Class II | RECLAIM Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical…The product can be difficult to remove from the Distal Stem both out of the package and after proximal… | 06/03/2014Terminated |
| Z-2083-2014 Class II | RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve.…The product can be difficult to remove from the Distal Stem both out of the package and after proximal… | 06/03/2014Terminated |