Class 2 Device Recall

• Date Initiated by Firm: August 01, 2003
• Date Posted: November 13, 2003
• Recall Status: Terminated on December 12, 2004
• Recall Number: Z-0107-04
• Recall Event ID: 27053
• Product Classification: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer - Product Code KRO
• Product: 17 mm thickness only of a polyethelene insert, which sits on the top of a metal component tibial implant. Part of the ''RT/RT Modular'' total knee replacement.
• Code Information: No code information applies.
• Recalling Firm/ Manufacturer: Plus Orthopedics; 6055 Lusk Blvd; San Diego CA 92121
• For Additional Information Contact: Niel Delaney; 888-741-7587 Ext. 2511
• Manufacturer Reason for Recall: Plastic insert over articular surface of knee joint replacement may become dislodged.
• FDA Determined Cause: Other
• Action: Firm telephoned each distributor to ensure that devices were not used in upcoming surgeries on 8/1 or 8/26/2003.
• Quantity in Commerce: 35
• Distribution: AZ, ID, TX CTdistributors.
• 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.