BEUDAMED
    FDA Recall Terminated

    Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion and removal.

    Recall: Z-0799-2020 · Initiated March 14, 2019

    Recall

    Recall Number
    Z-0799-2020
    Event Number
    84350
    Firm
    Trilliant Surgical, LLC
    FEI Number
    3007420745
    Product Code
    HXX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 14, 2019
    Terminated
    March 16, 2022
    Address
    727 N Shepherd Dr, Ste 100, Houston, TX, 77007-1320

    Description

    Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion and removal.

    Reason

    A screwdriver used to facilitate implant insertion and removal was found to be out of specification for the minor diameter of the drive feature causing the driver to be unable to retain screws as intended.

    Action

    The recall strategy included sending written recall communication and response forms as of 03/14/2019 via FedEx (Express Standard Overnight) to all consignees that showed possession / had been sold a device (as the device is considered reusable) as of 03/14/2019. The communication instructed the consignees to: " Check inventory stock for identified devices " Locate and remove and/or discontinue use of identified devices " Return all related product(s) to Recalling Firm in accordance with the included return response / acknowledgement form.

    Distribution

    US Nationwide distribution in the states of CO, CT, IA, TX and WI. OUS: None

    Quantity

    20 units