Class 2 Device Recall

• Date Initiated by Firm: June 07, 2005
• Date Posted: July 21, 2005
• Recall Status: Terminated on May 02, 2006
• Recall Number: Z-1024-05
• 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, STD; REF 1294-09-640.
• Code Information: Lots 1831720, 1831721, 1837366, 1837367, 1840603, 1845651 and 1855830.
• FEI Number: 1818910
• 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: 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