BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0799-2020 · Reported January 22, 2020

    Enforcement

    Recall Number
    Z-0799-2020
    Event ID
    84350
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Trilliant Surgical, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 22, 2020
    Initiation Date
    March 14, 2019
    Classification Date
    January 10, 2020
    Termination Date
    March 16, 2022
    Address
    727 N Shepherd Dr Ste 100, Houston, TX, 77007-1320, United States

    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.

    Code Info

    Part Number: 320-35-003 Lot Number: TSL006617 UDI: (01)00812926026893(10)TSL006617

    Distribution

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

    Quantity

    20 units