BEUDAMED
    FDA Recall 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 · Initiated July 31, 2015

    Recall

    Recall Number
    Z-2738-2015
    Event Number
    71936
    Firm
    Trilliant Surgical Ltd.
    FEI Number
    3007420745
    Product Code
    HRS
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    July 31, 2015
    Posted
    September 4, 2015
    Terminated
    January 26, 2017
    Address
    6721 Portwest Dr, Ste 160, Houston, TX, 77024-8019

    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.

    Action

    The firm sent out a written notification of the recall on 7/31/2015.

    Distribution

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

    Quantity

    108 units