Recall Z-2466-2008 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Encore Medical, Lp
FOUNDATION KNEE SYSTEM Tibial Fixed Impactor, Revision A and B; Catalog #801-01-449; distributed by Encore Medical, L.P., Austin, TX 78758. The Tibial Fixed Impactor, a part of the FOUNDATION KNEE SYSTEM, is a manual orthopedic surgical instrument intended to lock onto the baseplate to impact the implant.
| Date | Sep 29, 2008 (initiated Aug 4, 2008) |
| Status | Terminated |
| Reason | Complaints received regarding the fracture of the Nitronic 60 screw on the Tibial Fixed Impactor during surgery. |
| Root cause | Device Design |
| Action | Recall notification sent via letter starting on 08/04/07. Consignees asked to quarantine and return affected devices. Contact Encore Medical, Lp at 1-512-834-6330 for assistance. |
| Quantity | 68 units. |
| Distribution | FL and TX and OUS: Japan. |
| FDA record | Open on fda.gov |