Class 2 Device Recall

• Date Initiated by Firm: September 09, 2002
• Date Posted: November 27, 2003
• Recall Status: Terminated on December 30, 2003
• Recall Number: Z-0170-04
• Recall Event ID: 25007
• Product Classification: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
• Product: TC-PLUS Solution Femoral Component Size 12L, part 21041-C, lot 0006.13.2635.
• Code Information: Lot 0006.13.2635
• Recalling Firm/ Manufacturer: Plus Orthopedics; 6055 Lusk Blvd; San Diego CA 92121
• For Additional Information Contact: Neil Delaney; 888-741-7587 Ext. 2511
• Manufacturer Reason for Recall: Inaccurate dimensions of the device. Offshore manufacturer recalled product, some of which have been implanted.
• FDA Determined Cause: Other
• Action: Certified letters were sent out to the 2 providers that had implanted the device. The remaining inventory was exported back to the manufacturer.
• Quantity in Commerce: 5
• Distribution: TX,
• 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.