Class 2 Device Recall

• Date Initiated by Firm: January 04, 2005
• Date Posted: February 15, 2005
• Recall Status: Terminated on March 03, 2005
• Recall Number: Z-0540-05
• Recall Event ID: 30807
• 510(K)Number: K022204
• Product Classification: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
• Product: UltraCongruent Tibial Insert Model 0214703 Tibial Insert, Ultra-Congruent, Right, Size 3, 10mm
• Code Information: All of specific lot 044843
• Recalling Firm/ Manufacturer: Plus Orthopedics; 10188 Telesis Ct; San Diego CA 92121
• For Additional Information Contact: Natalie J. Kennel; 888-741-7587 Ext. 2526
• Manufacturer Reason for Recall: Knee tibial insert is mislabeled completely as different device.
• FDA Determined Cause: Other
• Action: PLUS Orthopedics QA department has identified a labeling eror on Article 0214703, affecting lot number 044843. This Ultra-congruent PE insert package may contain a Standard PE insert.
• Quantity in Commerce: 10, 1 is implanted.
• Distribution: California, Idaho, Illinois, Wisconsin, Oregon
• 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