Recall Z-2059-2010 ยท KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Depuy Orthopaedics, Inc.
DePuy ASR 300 Acetabular Implant, 70 mm, 999830770, sterile, DePuy International, Ltd, Leeds, United Kingdom.
| Date | Jul 17, 2010 (initiated Mar 5, 2010) |
| Status | Terminated |
| Reason | Notification to clinicians of new revision rate data/information regarding the use of the device. As part of the post-market surveillance, 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joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. As part of the post-m |
| Root cause | Other |
| Action | DePuy Orthopaedics issued a Field Safety Notice to share the new data with surgeons and to reiterate the importance of correct implant positioning and patient selection in achieving optimal implant performance and survivorshop. For additional information regarding this matter, please contact the DePuy Scientific Information Office at 888 554 2482. |
| Quantity | 12 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |