Recall Z-1775-2011 ยท KXA Prosthesis, Hip, Femoral, Resurfacing
Depuy Orthopaedics, Inc.
ASR FEMORAL IMPLANT SIZE 63, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used a
| Date | Mar 24, 2011 (initiated Aug 23, 2010) |
| Status | Terminated |
| Reason | As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. DePuy Orthopaedics issued a Field Safety Notice in March 2010 after receiving new data from the |
| Root cause | Device Design |
| Action | DePuy Orthopaedics issued a Field Safety Notice in March 2010 to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to share the Field Safety Notice with their organization and any organization where the ASR products may have been transferred. Customer were instructed not to implant the ASR devices. Patients who received the ASR System should be informed of this recall and instructed to return for a follow up visit. Patients with radiographic changes indicative of product failure should be addressed |
| Quantity | 29 |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032659 | DEPUY ASR RESURFACING FEMORAL HEADS DePuy Orthopaedics, Inc., Dec 4, 2003 |