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Terminated

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.

FDA Recall Z-2070-2012 · Posted 2012-07-24

Recalling FirmExactech, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2011-09-23
Date Terminated2014-06-11
Product Quantity16

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.

Firm 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.

Root Cause

Labeling mix-ups

Distribution Pattern

Worldwide Distribution-USA-including the states of CA, MA, OH, and OK, and the countries of Brazil, Colombia, France, Italy, Japan, Luxembourg, and Spain.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K933610EXACTECH CEMENTED TOTAL KNEE SYSTEM, TIBIAL COMPONENTSExactech, Inc. · 1995-01-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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