Recall Z-0523-06 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Wright Medical Technology Inc
Guardian Distal Femur Axial Pin
| Date | Feb 16, 2006 (initiated Jan 3, 2006) |
| Status | Terminated |
| Reason | The product was not fully assembled prior to packaging. |
| Root cause | Other |
| Action | The firm sent out recall notices to implanting surgeons by letter dated 01/10/2005 to notify the surgeons of the issue. |
| Quantity | 10 |
| Distribution | Nationwide and PR |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013035 | GUARDIAN LIMB SALVAGE SYSTEM Wrightmedicaltechnologyinc, Dec 7, 2001 |