Recall Z-0953-2013 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Exactech, Inc.
Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508.
| Date | Mar 15, 2013 (initiated Feb 1, 2013) |
| Status | Terminated |
| Reason | A dimensional mismatch was identified which can potentially allow for interference between devices. |
| Root cause | Device Design |
| Action | Exactech Inc. sent a *** Important *** Product Market Recall Notice dated January 30, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 1. Customers were instructed to immediately cease distribution or use of these products. 2. Extend this information to your accounts that may have this product in their possession. 3. Verify if you have any of the subject Optetrak Logic Proxima Tibial Spacer (PTS) in the specified lots. Please complete the attached fax back form and return it to Exactech within the next 5 workin |
| Quantity | 123 devices |
| Distribution | Nationwide Distribution including the states of FL, AL, LA, PA, VA, IL, OH, NY, NC, KS, TN, NJ, CO, GA, CA, MD, MN, IN, & Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071738 | EXACTECH OPTETRAK PROXIMAL TIBIAL SPACER Exactech, Inc., Aug 15, 2007 |