—#109647

Product

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 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.

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K093360
Affected lot / code info: Catalog numbers 02-012-35-6011, 02-012-35-6013, 02-012-35-6015 All lots.

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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 at their location. If you have any questions regarding inventory restocking issue, please call -800-392-2832.

Recalling firm

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

Distribution

Distribution pattern: USA ( nationwide) WA, OH, OK, TX, NC, NY, CO, VA, MA, IL, TN, MN, NJ and FL.

Timeline

Recall initiated: 2011-08-19
Posted by FDA: 2012-09-04
Terminated: 2013-11-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #109647. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.