—#39725

Product

Depuy P.F.C. E knee system, all polyethylene curved tibial component, Sz 3, 10 mm; Ref 96-0641.

FDA product code: NJL — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P830055S084
Affected lot / code info: Lots 84179A, 85601A, 85978A, 86003A, 86045A and 86291A.

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 #39725. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.