Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 30.0mm, 67mm M/L, 45 mm A/P, 30.0 mm, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0527.

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.

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.