Recall Z-2084-2014 ยท KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
DePuy Orthopaedics, Inc.
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.
| Date | Jul 21, 2014 (initiated Jun 3, 2014) |
| Status | Terminated |
| Reason | The product can be difficult to remove from the Distal Stem both out of the package and after proximal reaming. |
| 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 informat |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102080 | DEPUY RECLAIM REVISION HIP SYSTEM Depuy(Ireland), Nov 23, 2010 |