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U.S. Department of Health and Human Services

Class 2 Device Recall LCS Complete

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  Class 2 Device Recall LCS Complete see related information
Date Initiated by Firm May 26, 2005
Date Posted August 12, 2005
Recall Status1 Terminated 3 on December 02, 2005
Recall Number Z-1129-05
Recall Event ID 32192
PMA Number P830055S074 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing - Product Code NJL
Product Depuy LCS Complete RP insert; polyethylene tibial insert STD+, 17.5 mm; Ref 1294-05-517.
Code Information Lots Y24CE4, Y24CF4, Y37D14 and Y37DX4. 
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
Quantity in Commerce 40
Distribution Nationwide, Argentina, Brazil, Canada, Caguas, Colombia, Ireland, Malaysia, Mexico, Panama, Peru, Singapore, South Africa, Sweden, Uruguay and Venezuela.
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.