—#64596

Product

Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 76 mm M/L, 51 mm A/P, 10.0 mm, 4, UHMWPE, sterile; Product Code/REF 96-0451.

FDA product code: NJL — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
Device class: Class 3
Medical specialty: Unknown
510(k) numbers: K950010
Affected lot / code info: Lots 80370A and 80373A.

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)

Packaging process control

Action the firm took

Consignee hospitals and implanting physicians were notified of the recall via an Urgent Information-Recall Notice letter and Dear Doctor letters dated 9/27/07. The hospitals were instructed to determine whether they had any of the recalled products and to contact their sales representative to pick up the product. Depuy sales representatives were notified to collect the products from consignee hospitals via email on 10/1/07. The decision to discuss this product defect with patients who had already been implanted was left to the implanting physicians.

Recalling firm

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

Distribution

Distribution pattern: Nationwide.

Timeline

Recall initiated: 2007-09-27
Posted by FDA: 2007-12-06
Terminated: 2008-04-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #64596. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.