Recall Z-0276-2008 ยท KXA Prosthesis, Hip, Femoral, Resurfacing
Zimmer Inc.
Zimmer Durom Hip Resurfacing Systems, Femoral Component 46 Code L; Catalog No.: 01.00211.146, Lot 2376766. Zimmer, Warsaw, IN, 46581-0708.
| Date | Nov 29, 2007 (initiated Sep 26, 2007) |
| Status | Terminated |
| Reason | Mislabeled as to size; 54mm package contains 46 mm device and vice versa. |
| Root cause | Packaging process control |
| Action | Zimmer GmbH notified Distributors via a Product Recall Notification letter, dated 9/26/07, instructing them to return the products and to subrecall. |
| Quantity | 5 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070292 | DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS Zimmer GmbH, Apr 26, 2007 |