Recall Z-0560-04 ยท JDL Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
Stryker Howmedica Osteonics
Crossfire Acetabular II Insert. Catalog No: 2041C-2642.
| Date | Jul 20, 2004 (initiated Jan 9, 2004) |
| Status | Terminated |
| Reason | This device is not approved for sale in the US. |
| Root cause | Other |
| Action | Letters dated 1/9/2004 and 1/12/2004 were sent to Surgical Resources and Dr. Vorenkamp alerting them to the situation. |
| Quantity | 3 (1 unit in US) |
| Distribution | The one device was shipped to Surgical Resources, 1150 Torrey Road, Suite A, Fenton, MI 48430 for Dr. Steven E. Vorenkamp, M.D., Petoskey, MI.. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.