Recall Z-1405-04 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Wright Medical Technology Inc
Guardian Distal Femur Axial Pin
| Date | Aug 24, 2004 (initiated Jul 14, 2004) |
| Status | Terminated |
| Reason | Potential for self -locking axial pin to dislodge and 'back out'. |
| Root cause | Other |
| Action | The firm sent out product correction notifications to implanting surgeons by letter dated 07/14/2004 to notify the surgeons of the dislodgement issue. |
| Quantity | 44 |
| Distribution | Nationwide. Ontario, and Taiwan, ROC |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013035 | GUARDIAN LIMB SALVAGE SYSTEM Wrightmedicaltechnologyinc, Dec 7, 2001 |