Class 2 Device Recall Trapezoid Tibial Tray

• Date Initiated by Firm: November 11, 2004
• Date Posted: December 23, 2004
• Recall Status: Terminated on May 03, 2012
• Recall Number: Z-0347-05
• Recall Event ID: 30540
• 510(K)Number: K933610
• Product Classification: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
• Product: Cemented Trapezoid Tibial Tray Sz. 4F/4T, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
• Code Information: Serial numbers 0638851-0638871
• Recalling Firm/ Manufacturer: Exactech, Inc.; 2320 NW 66th Ct; Gainesville FL 32653-1630
• Manufacturer Reason for Recall: Implant was identified incorrectly at the time of manufacture and was then labeled and distributed with the incorrect size information.
• FDA Determined Cause: Other
• Action: A recall letter was sent to all customers on November, 2, 2004 recalling all 21 units. These implants will be quarantined and then returned to the supplier for disposal when all 21 implants are received.
• Quantity in Commerce: 21 implants
• Distribution: Distributed to New Jersey, Florida, Minnesota, New York, Maryland, Texas and the United Kingdom
• 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