—#40348

Product

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***''.

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K932776
Affected lot / code info: Serial number range 0696020 - 0696061.

Why it was recalled

Implant was identified incorrectly at the time of manufacture and then laser etched with the incorrect size information.

Root cause (FDA determination)

Other

Action the firm took

All consignees were notified by letter on 06/02/2005.

Recalling firm

Firm: Exactech, Inc.
Address: 2320 NW 66th Ct, Gainesville, Florida 32653-1630

Distribution

Distribution pattern: Distributed to 15 Domestic Consignees 4 Foreign Distributors.

Timeline

Recall initiated: 2005-06-02
Posted by FDA: 2005-08-18
Terminated: 2008-10-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #40348. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.