BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-2310-2012 · Initiated August 19, 2011

    Recall

    Recall Number
    Z-2310-2012
    Event Number
    61984
    Firm
    Exactech, Inc.
    FEI Number
    1038671
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 19, 2011
    Posted
    September 4, 2012
    Terminated
    November 7, 2013
    Address
    2320 NW 66th Ct, Gainesville, FL, 32653-1630

    Description

    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.

    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.

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

    Distribution

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

    Quantity

    193