Recall Z-0474-2007 ยท KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Stryker Howmedica Osteonics Corp.
Howmedica Hip Fracture Stem System No. 3 Femoral Component Fenestrated Sterile REF Catalogue #6942-0-030 Made in Ireland
| Date | Jan 13, 2007 (initiated Nov 28, 2006) |
| Status | Terminated |
| Reason | Lack of assurance of Sterility (package integrity): Anomalies in seal width and strength that may affect the integrity of the sterile barrier. |
| Root cause | Other |
| Action | Recall notification letters and product accountability forms were sent on 11/29 via Fed Ex with return receipt. |
| Quantity | 540 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.