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U.S. Department of Health and Human Services

Class 2 Device Recall Depuy P.F.C. E RP Knee System

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  Class 2 Device Recall Depuy P.F.C. E RP Knee System see related information
Date Initiated by Firm September 27, 2007
Date Posted December 06, 2007
Recall Status1 Terminated 3 on April 30, 2008
Recall Number Z-0411-2008
Recall Event ID 44893
PMA Number P830055S077 
Product Classification Tibial Insert - Product Code NJL
Product Depuy P.F.C. ¿ E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 12.5 mm, Size 3, UHMWPE, sterile; Product Code/REF 96-2132.
Code Information Lots 79635A, 79856A, 79861A, 79865A, 80656A, 80661A and 80655A.
Recalling Firm/
Depuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information Contact
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Packaging process control
Action 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.
Quantity in Commerce 77
Distribution Nationwide.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = NJL and Original Applicant = DEPUY, INC.