—#49751

Product

Polyethylene tibial posterior stabilized components. Optetrak All Poly Tibial PS Component. Knee prosthesis. Catalog number : 204-11-13

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K933494
Affected lot / code info: serial numbers: 0900529-0900532

Why it was recalled

The outside profile on this manufactured lot of devices is oversized and does not meet specifications.

Root cause (FDA determination)

Other

Action the firm took

Letter dated 12/08/06. The firm representative retrieved all four devices from the field.

Recalling firm

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

Distribution

Distribution pattern: Distributed to one hospital in New York.

Timeline

Recall initiated: 2006-12-07
Posted by FDA: 2007-02-27
Terminated: 2012-07-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #49751. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.