Recall Z-2071-2012 ยท NJL Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing
Exactech, Inc.
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,
| Date | Jul 24, 2012 (initiated Sep 23, 2011) |
| Status | Terminated |
| Reason | 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 | 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 | 12 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.