—#36077

Product

Cemented Trapezoid Tibial Tray Sz. 4F/4T, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K933610
Affected lot / code info: Serial numbers 0638851-0638871

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

A recall letter was sent to all customers on November, 2, 2004 recalling all 21 units. These implants will be quarantined and then returned to the supplier for disposal when all 21 implants are received.

Recalling firm

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

Distribution

Distribution pattern: Distributed to New Jersey, Florida, Minnesota, New York, Maryland, Texas and the United Kingdom

Timeline

Recall initiated: 2004-11-11
Posted by FDA: 2004-12-23
Terminated: 2012-05-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #36077. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.