BEUDAMED
    FDA Enforcement Class II Terminated

    Cannulated Driver Handle, Catalog #: 210-00-003, Rx Only, Non Sterile

    Recall: Z-2338-2018 · Reported July 11, 2018

    Enforcement

    Recall Number
    Z-2338-2018
    Event ID
    80195
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Trilliant Surgical Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 11, 2018
    Initiation Date
    March 27, 2018
    Classification Date
    July 2, 2018
    Termination Date
    June 4, 2020
    Address
    727 N Shepherd Dr Ste 100, Houston, TX, 77007-1320, United States

    Description

    Cannulated Driver Handle, Catalog #: 210-00-003, 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.

    Code Info

    Lot: 603599

    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

    94