Recall Z-0885-2009 ยท HWT Template
Zimmer Inc.
Zimmer NEXGEN Complete Knee Solution Cruciate Retaining (CR) Provisional - Articular surface, Size Blue, 14 MM Height, nonsterile, Zimmer, Warsaw, IN; REF 5971-50-14. Used during total knee arthroplasty surgery to determine the required thickness of the tibial bearing surface to be implanted. Reusable, non-implantable.
| Date | Jan 23, 2009 (initiated Dec 12, 2008) |
| Status | Terminated |
| Reason | Some 12 mm thick devices may have been etched and packaged as 14 mm thick, and vice versa. |
| Root cause | Employee error |
| Action | Zimmer sales force and distribution sites were notified of the recall via email on 12/15/08 and instructed to inventory, return the affected products and to provide a copy of the recall letter to those customers to whom they had further distributed the products. The 'Urgent: Device Recall" letter dated 12/12/08, described the problem and the potential risks. For additional information, contact Zimmer, Inc., at 1-800-613-6131. |
| Quantity | 131 of both products. |
| Distribution | Nationwide, Canada, Denmark, Finland, Germany, Poland, Spain, Sweden and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.