—#39875

Product

Depuy P.F.C. Modular Knee System, posterior-lipped tibial insert (PLI); polyethylene tibial insert, Sz 3, 12.5 mm; Ref 98-4610.

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K884796
Affected lot / code info: Lot 84328A.

Why it was recalled

An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

Root cause (FDA determination)

Other

Recalling firm

Firm: Depuy Orthopaedics, Inc.
Address: 700 Orthopaedic Dr, Warsaw, Indiana 46582-3994

Distribution

Distribution pattern: Nationwide, Argentina, Brazil, Canada, Caguas, Colombia, Ireland, Malaysia, Mexico, Panama, Peru, Singapore, South Africa, Sweden, Uruguay and Venezuela.

Timeline

Recall initiated: 2005-05-26
Posted by FDA: 2005-08-12
Terminated: 2005-12-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #39875. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.