Recall Z-0522-2007 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Exactech, Inc.
Polyethylene tibial posterior stabilized components. Optetrak All Poly Tibial PS Component. Knee prosthesis. Catalog number : 204-11-13
| Date | Feb 27, 2007 (initiated Dec 7, 2006) |
| Status | Terminated |
| Reason | The outside profile on this manufactured lot of devices is oversized and does not meet specifications. |
| Root cause | Other |
| Action | Letter dated 12/08/06. The firm representative retrieved all four devices from the field. |
| Quantity | 4 units |
| Distribution | Distributed to one hospital in New York. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K933494 | EXACTECH POSTERIOR STABILIZED CEMENTED TOTAL KNEE SYSTEM Exactech, Inc., Mar 10, 1995 |