Class 2 Device Recall Optetrak

• Date Initiated by Firm: December 07, 2006
• Date Posted: February 27, 2007
• Recall Status: Terminated on July 11, 2012
• Recall Number: Z-0522-2007
• Recall Event ID: 37005
• 510(K)Number: K933494
• Product Classification: knee prosthesis - Product Code JWH
• Product: Polyethylene tibial posterior stabilized components. Optetrak All Poly Tibial PS Component. Knee prosthesis. Catalog number : 204-11-13
• Code Information: serial numbers: 0900529-0900532
• FEI Number: 1038671
• Recalling Firm/ Manufacturer: Exactech, Inc.; 2320 NW 66th Ct; Gainesville FL 32653-1630
• Manufacturer Reason for Recall: The outside profile on this manufactured lot of devices is oversized and does not meet specifications.
• FDA Determined Cause: Other
• Action: Letter dated 12/08/06. The firm representative retrieved all four devices from the field.
• Quantity in Commerce: 4 units
• Distribution: Distributed to one hospital in New York.
• 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