Class 2 Device Recall TCPLUS Solution

• Date Initiated by Firm: August 03, 2005
• Date Posted: October 07, 2005
• Recall Status: Terminated on June 16, 2006
• Recall Number: Z-0014-06
• Recall Event ID: 32882
• 510(K)Number: K000666
• Product Classification: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
• Product: TC-PLUS Tibial Insert 2; 15mm, Model 25309
• Code Information: Lot code: 0303.13.1623
• 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: Did not meet specifications.
• FDA Determined Cause: Other
• Action: Recall was by scripted telephone conversations to two consignees. Products were returned under RMA.
• Quantity in Commerce: 21
• Distribution: Arizona, California, Idaho, New York, Texas, and Virginia
• 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