BEUDAMED
    FDA Recall Terminated

    Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508.

    Recall: Z-0953-2013 · Initiated February 1, 2013

    Recall

    Recall Number
    Z-0953-2013
    Event Number
    64465
    Firm
    Exactech, Inc.
    FEI Number
    1038671
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 1, 2013
    Posted
    March 15, 2013
    Terminated
    September 22, 2014
    Address
    2320 NW 66th Ct, Gainesville, FL, 32653-1630

    Description

    Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508.

    Reason

    A dimensional mismatch was identified which can potentially allow for interference between devices.

    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 working days. Thank you for your prompt attention to this matter. For further questions please call (352) 377-1140.

    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.

    Quantity

    123 devices