Recall Z-0090-2008 ยท KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Encore Medical, Lp
Foundation Hip System Bipolar Modular, Size 48mm OD; Cat. #412-01-048; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758.
| Date | Nov 7, 2007 (initiated Aug 2, 2007) |
| Status | Terminated |
| Reason | Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date. |
| Root cause | Packaging change control |
| Action | Firm notified consignees of recall via phone, e-mail and overnight letters beginning on 08/02/07. Consignees asked to return devices for a properly labeled replacement. |
| Quantity | 377 units. |
| Distribution | Worldwide, including USA, Greece, Japan, and Saudi Arabia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K953510 | HIP JOINT FEMORAL (HEMI-HIP) METAL/POLYMER CEMENTED OR UNCEMENTED PROSTHESIS Encore Orthopedics, Inc., Aug 9, 1995 |