Class 3 Device Recall

• Date Initiated by Firm: February 22, 2005
• Date Posted: November 03, 2005
• Recall Status: Terminated on February 05, 2007
• Recall Number: Z-0126-06
• Recall Event ID: 32837
• 510(K)Number: K000666
• Product Classification: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
• Product: TC-PLUS Solution Femoral Component, model 21028, Femoral component, right, size 8.
• Code Information: Exp Date of 2011. No serial number. Lot number 0411.13.6556.
• FEI Number: 3001237832
• Recalling Firm/ Manufacturer: Plus Orthopedics USA; 10188 Telesis Ct; San Diego CA 92121-4779
• For Additional Information Contact: Natalie J. Kennel; 888-741-7587 Ext. 2526
• Manufacturer Reason for Recall: Labeling discrepancy.
• FDA Determined Cause: Other
• Action: Firm retrieved the unit from the consignee and returned it to the manufacturer. Firm indicates that Operations contacted the agent site and requested the return.
• Quantity in Commerce: 1 unit
• Distribution: NY
• 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