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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm June 07, 2005
Date Posted July 21, 2005
Recall Status1 Terminated 3 on May 02, 2006
Recall Number Z-1027-05
Recall Event ID 32282
PMA Number P830055/R44 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing - Product Code NJL
Product Depuy brand LCS Complete metal backed patella, porocoat, LRG+; REF 1294-09-670.
Code Information Lot 1851632.
Recalling Firm/
Manufacturer		 Depuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw IN 46582-3994
For Additional Information Contact
800-366-8143
Manufacturer Reason
for Recall		 There may be dissociation of the polyethylene from the baseplate because the inside diameter of the polyethylene articular bearing was manufactured to an oversized condition.
FDA Determined
Cause 2		 Other
Action Hospitals were notified via letter dated June 10, 2005 requesting that they quarantine product on hand and send in a response card to the firm.
Distribution Nationwide and international.
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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