—#109674

Product

Product is labeled in part: "***OPTETRAK RBK***TIBIAL TRAY***FINNED, CEMENTED***CoCr Alloy***SIZE 2F/1T***REF 260-04-21***Exactech Gainesville, FL 32653-1630***. The Exactech Optetrak RBK Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for knee pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders and/or avascular necrosis of the femoral condyle, post-traumatic loss of the joint configuration (particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Additionally, the Optetrak RBK Total Knee System is indicated for cases where revision of failed previous surgical attempts is necessary, if the knee can be satisfactorily balanced and stabilized at the time of surgery.

FDA product code: NJL — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
Device class: Class 3
Medical specialty: Unknown
Affected lot / code info: Serial number range 2067544 - 2067555.

Why it was recalled

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.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

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.

Recalling firm

Firm: Exactech, Inc.
Address: 2320 NW 66th Ct, Gainesville, Florida 32653-1630

Distribution

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.

Timeline

Recall initiated: 2011-09-23
Posted by FDA: 2012-07-24
Terminated: 2014-06-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #109674. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.