Class 2 Device Recall Optetrak

• Date Initiated by Firm: August 31, 2006
• Date Posted: November 21, 2006
• Recall Status: Terminated on May 03, 2012
• Recall Number: Z-0196-2007
• Recall Event ID: 36311
• 510(K)Number: K010434
• Product Classification: Tibial Tray - Product Code JWH
• Product: Optetrak, B-series cemented finned tibial tray size 2f/2t. Catalog # 220-04-02
• Code Information: Serial numbers 0886395-0886424
• Recalling Firm/ Manufacturer: Exactech, Inc.; 2320 NW 66th Ct; Gainesville FL 32653-1630
• Manufacturer Reason for Recall: Improperly machined parts: The Cemented Finned Tibial Trays could not seat the size 2 mating trial or polyethylene insert.
• FDA Determined Cause: Other
• Action: The recall was initiated on August 31, 2006. The distributors were notified by FAX, email and telephone. The returned devices will be stored quarantine.
• Quantity in Commerce: 30
• Distribution: International distribution only---- including countries of South America, Africa and Europe
• 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 and Original Applicant = EXACTECH, INC.