Recall Z-2310-2012 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Exactech, Inc.
OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 YELLOW, 11mm, Use with LOGIC Femoral and Tibial Components***REF 02-012-35-6011. There are three product sizes being recalled, 11mm, 13mm, 15mm. All other information is the same. The Optetrak Logic Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacem
| Date | Sep 4, 2012 (initiated Aug 19, 2011) |
| Status | Terminated |
| Reason | Exactech, Inc. of Gainesville, FL is recalling their Optetrak Logic Posterior Stabilized Tibial Insert, Size 6 after the device was determined to be out of dimensional specification. |
| Root cause | Device Design |
| Action | Exactech, Inc., sent an "IMPORTANT PRODUCT MARKET WITHDRAWAL NOTICE" letter dated August 19, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed to: 1. Immediately cease distribution or use of the products. 2. Extend the information to accounts that are in possession of the products. 3. Verify if they had any of the affected products on the list. 4. Fax back the attached form. In addition, they were instructed to contact the Exactech inventory representative to confirm quantities a |
| Quantity | 193 |
| Distribution | USA ( nationwide) WA, OH, OK, TX, NC, NY, CO, VA, MA, IL, TN, MN, NJ and FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093360 | OPTETRAK LOGIC TOTAL KNEE SYSTEM TRAPEZOIDAL TIBIAL TRAY, SIZES 2.5F/1.5T-3.5F/4.5T Exactech, Inc., Jan 11, 2010 |