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U.S. Department of Health and Human Services

Class 2 Device Recall OPTETRAKTIBIAL TRAY

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  Class 2 Device Recall OPTETRAKTIBIAL TRAY see related information
Date Initiated by Firm September 23, 2011
Date Posting Updated July 24, 2012
Recall Status1 Terminated 3 on June 11, 2014
Recall Number Z-2070-2012
Recall Event ID 61969
510(K)Number K933610  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product Product is labeled in part: "***OPTETRAK***TIBIAL TRAY***TRAPEZOID CEMENTED***Ti Alloy*** SIZE 1F/1T, 2F/1T***FOR CEMENTED USE ONLY***Exactech, Gainesville, FL 32653-1630.***REF 204-04-21***".

The Optetrak Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. In the USA, the Optetrak Comprehensive Knee System is indicated for cemented use only.
Code Information Serial number range 2067442 - 2067457.
Recalling Firm/
Manufacturer
Exactech, Inc.
2320 NW 66th Ct
Gainesville FL 32653-1630
For Additional Information Contact Graham L. Cuthbert
352-327-4613
Manufacturer Reason
for Recall
Exactech, Inc. Gainesville, FL is recalling their Optetrak Cemented Trapezoid Tibial Tray, Size 1F/1T, 2F/1T and the Optetrak Rotating Bearing Knee Tibial Tray, Finned, Cemented Tibial Tray, Size 2F/1T. Both trays have the potential to be mislabeled.
FDA Determined
Cause 2
Labeling mix-ups
Action Exactech, Inc. sent an "IMPORTANT MARKET WITHDRAWAL NOTICE" on September 23, 2011, to all affected customers. The customers were instructed to: 1. Immediately cease distribution or use of the products. 2. Extend the information to accounts that has possession of the products. 3. Verify if they have any of the affected products listed. 4. Fax back the attached form. Customers were instructed to contact Exactech inventory representative to confirm quantities at their location. For questions regarding any inventory restocking, the customers were directed to contact Kaya Davis 1-800-392-2832.
Quantity in Commerce 16
Distribution Worldwide Distribution-USA-including the states of CA, MA, OH, and OK, and the countries of Brazil, Colombia, France, Italy, Japan, Luxembourg, and Spain.
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.
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