Recall Z-0571-04 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Stryker Howmedica Osteonics
Restoration T3 Revision Hip System, Femoral Hip Prosthesis. Various lengths and Model numbers. 6260-3-014 T3 MOD REV DIST STM 14MMX225MM; 6260-3-015 T3 MOD REV DIST STM 15MMX225MM; 6260-3-016 T3 MOD REV DIST STM 16MMX225MM; 6260-3-017 T3 MOD REV DIST STM 17MMX225MM; 6260-3-018 T3 MOD REV DIST STM 18MMX225MM; 6260-3-019 T3 MOD REV DIST STM 19MMX225MM; 6260-3-020 T3 MOD REV DIST STM
| Date | Jul 20, 2004 (initiated Dec 30, 2003) |
| Status | Terminated |
| Reason | Restoration T3 Revision Hip System distal stem has demonstrated fractures. |
| Root cause | Other |
| Action | Product recall letters and accountability forms were sent via FedEx on 12/30/2003 with return receipt. |
| Quantity | 8986 |
| Distribution | The following direct accounts received the device: Branches/Agencies: 46; Hospitals: 526; Government Hospitals: 23; International Distributors: 10; Latin America: 3; Canada: 1; and Asia Pacific: 3. |
| FDA record | Open on fda.gov |