Class 2 Device Recall Preservation

• Date Initiated by Firm: May 26, 2005
• Date Posted: August 12, 2005
• Recall Status: Terminated on December 02, 2005
• Recall Number: Z-1147-05
• Recall Event ID: 32192
• 510(K)Number: K010810
• Product Classification: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing - Product Code NJL
• Product: Depuy Preservation Uni Knee All Poly Tibial; polyethylene tibial insert LM/RL, Sz 2, 7.0 mm; Ref 1498-12-206.
• Code Information: Lots X74FV4, Y48DP4, Y48DR4, Y54D94, Y54EA4, Y5EFR4, Y5EFS4 and Y5GEF4.
• 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: Other
• Quantity in Commerce: 96
• 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.

• 510(K) Database: 510(K)s with Product Code = NJL