BEUDAMED
    FDA Enforcement Class II Terminated

    2.4, 3.0, and 4.0 mm Gridlock Screw Driver Bit, Model Number 310-30-003, Lot Number TSL002605, NON-STERILE. For use with the Gridlock Plating System for trauma and reconstructive procedures of small bones.

    Recall: Z-2738-2015 · Reported September 16, 2015

    Enforcement

    Recall Number
    Z-2738-2015
    Event ID
    71936
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Trilliant Surgical Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 16, 2015
    Initiation Date
    July 31, 2015
    Classification Date
    September 4, 2015
    Termination Date
    January 26, 2017
    Address
    6721 Portwest Dr Ste 160, N/A, Houston, TX, 77024-8019, United States

    Description

    2.4, 3.0, and 4.0 mm Gridlock Screw Driver Bit, Model Number 310-30-003, Lot Number TSL002605, NON-STERILE. For use with the Gridlock Plating System for trauma and reconstructive procedures of small bones.

    Reason

    Gridlock screw driver bits for the Gridlock Plating System were identified to be out of specification and have the potential for shallow engagement between the driver and the screw, resulting in an increased likelihood of stripping screw heads intraoperatively. Specifically, the minor diameter of the drive feature is above the specification, potentially reducing the engagement between the driver and the screw head.

    Code Info

    TSL002605

    Distribution

    NY, OH, CA, SC, NJ, AZ, VA, IN, FL, MN, OK, AR, MO, WI, GA, SD, IA, IL, TX

    Quantity

    108 units