BEUDAMED
    FDA Recall Terminated

    Ratcheting Cannulated Driver Handle, Catalog #: 210-00-004, Rx Only, Non Sterile

    Recall: Z-2339-2018 · Initiated March 27, 2018

    Recall

    Recall Number
    Z-2339-2018
    Event Number
    80195
    Firm
    Trilliant Surgical Ltd.
    FEI Number
    3007420745
    Product Code
    MDM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 27, 2018
    Terminated
    June 4, 2020
    Address
    727 N Shepherd Dr, Ste 100, Houston, TX, 77007-1320

    Description

    Ratcheting Cannulated Driver Handle, Catalog #: 210-00-004, Rx Only, Non Sterile

    Reason

    Firm is voluntarily recalling cannulated driver handles (210-00-003 and 210-00-004) that may demonstrate a degradation of function with the adapter collar sticking, and/or not retaining the mating adapter male shaft.

    Action

    On 03/27/18, the firm sent Medical Device Recall notices to customers informing them to: 1) Check inventory stock for identified devices; 2) Locate and remove and/or discontinue use of identified devices; 3) Return all related product(s) to the firm in accordance with an included return response / acknowledgement form. Customers were instructed to contact the firm at 1-800-495-2919 to organize product returns.

    Distribution

    U.S. States: NE, MA, GA, TX, OR, AZ, FL, OH, WA, NJ, UT, VA, CA, MN, PA, DE, OK, KS, WI, MT, IA, MO

    Quantity

    90