Restoration T3 Revision Hip System, Femoral Hip Prosthesis. Various lengths and Model numbers. 6260-3-014 T3 MOD REV DIS
FDA device recall Z-0571-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics
- Reason for recall
- Restoration T3 Revision Hip System distal stem has demonstrated fractures.
- Action taken
- Product recall letters and accountability forms were sent via FedEx on 12/30/2003 with return receipt.
- Root cause
- Other
- Status
- Terminated
- Product code
- LZO
- Quantity affected
- 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.
- Date initiated
- 2003-12-30
- Date posted
- 2004-07-20
- Date terminated
- 2006-02-07
- Location
- Mahwah, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 2 PIECE MODULAR HIP STEM (K013106) | Howmedica Osteonics Corp. | 2002-04-03 |
| TYPE 3 FEMORAL COMPONENTS (K983404) | Howmedica Corp. | 1998-12-22 |