—#48397

Product

Optetrak, B-series cemented finned tibial tray size 2f/2t. Catalog # 220-04-02

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K010434
Affected lot / code info: Serial numbers 0886395-0886424

Why it was recalled

Improperly machined parts: The Cemented Finned Tibial Trays could not seat the size 2 mating trial or polyethylene insert.

Root cause (FDA determination)

Other

Action the firm took

The recall was initiated on August 31, 2006. The distributors were notified by FAX, email and telephone. The returned devices will be stored quarantine.

Recalling firm

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

Distribution

Distribution pattern: International distribution only---- including countries of South America, Africa and Europe

Timeline

Recall initiated: 2006-08-31
Posted by FDA: 2006-11-21
Terminated: 2012-05-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #48397. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.