Class 2 Device Recall P.F.C.

• Date Initiated by Firm: May 26, 2005
• Date Posted: August 12, 2005
• Recall Status: Terminated on December 02, 2005
• Recall Number: Z-1163-05
• Recall Event ID: 32192
• 510(K)Number: K033272
• Product Classification: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
• Product: Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 4, 8 mm; Ref 1581-14-008.
• Code Information: Lots XY7B84 and Y5RDJ4.
• 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: 18
• 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 = JWH and Original Applicant = DEPUY ORTHOPAEDICS, INC.