Recall Z-1379-05 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Exactech, Inc.
The product is a Finned Tibial Tray. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P 53 mm ML 83mm***4F/5T Ti Alloy FITS ONLY SZ. 4 FEMORAL CEMENTED***STERILE, SINGLE USE ONLY. FOR CEMENTED USE ONLY***''.
| Date | Aug 18, 2005 (initiated Jun 2, 2005) |
| Status | Terminated |
| Reason | Implant was identified incorrectly at the time of manufacture and then laser etched with the incorrect size information. |
| Root cause | Other |
| Action | All consignees were notified by letter on 06/02/2005. |
| Quantity | 41 |
| Distribution | Distributed to 15 Domestic Consignees 4 Foreign Distributors. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K932776 | CRUCIATE RETAINING CEMENTED TIBIAL COMPONENTS Exactech, Inc., Oct 20, 1994 |