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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-1132-05
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 LG, 12.5 mm; Ref 1294-05-612.
Code Information Lots X24BH4, X3TA24, X3TA34, Y12EL4, Y46C74, and Y4XCF4. 
Recalling Firm/
Manufacturer		 Depuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information Contact
800-366-8143
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		 Other
Quantity in Commerce 60
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.
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