BEUDAMED
    FDA Recall Terminated

    Truliant Tibial Trial Handle. To assist the surgeon in the implantation of Truliant Knee system components according to a conventional technique for total knee replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.t Tibial Trial Handle

    Recall: Z-3018-2017 · Initiated June 23, 2017

    Recall

    Recall Number
    Z-3018-2017
    Event Number
    77592
    Firm
    Exactech, Inc.
    FEI Number
    1038671
    Product Code
    MDM
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    June 23, 2017
    Terminated
    November 30, 2020
    Address
    2320 NW 66th Ct, Gainesville, FL, 32653-1630

    Description

    Truliant Tibial Trial Handle. To assist the surgeon in the implantation of Truliant Knee system components according to a conventional technique for total knee replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.t Tibial Trial Handle

    Reason

    The Truliant Tibial Trial Handle's pin may disassociate from the main body.

    Action

    Exactech sent an "Important Notification" letter dated June 23, 2017, and Customers were notified via email on June 23, 2017. Instructions included to cease distribution of the product, notify customers if distributed, quarantine any affected devices, return affected devices, and complete and return the response form. For further questions, please call (352) 377-1140.

    Distribution

    US Distribution to the states of : AZ, CA, CO, FL, IL, OH, OK, NV, NY, SC and TN.

    Quantity

    68 devices