BEUDAMED
    FDA Enforcement Class II Terminated

    3.0/4.0 Cannulated Drill Bit; a component of the Tiger Cannulated Screw System The Tiger Cannulated Screw Fixation System implants are intended for fixation of fractures, non-unions, arthrodesis and osteotomies of the small bones in the hand and foot. The implants and guide wires are intended for single use only.

    Recall: Z-2452-2015 · Reported September 2, 2015

    Enforcement

    Recall Number
    Z-2452-2015
    Event ID
    71812
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Trilliant Surgical Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 2, 2015
    Initiation Date
    July 20, 2015
    Classification Date
    August 24, 2015
    Termination Date
    January 26, 2017
    Address
    6721 Portwest Dr Ste 160, N/A, Houston, TX, 77024-8019, United States

    Description

    3.0/4.0 Cannulated Drill Bit; a component of the Tiger Cannulated Screw System The Tiger Cannulated Screw Fixation System implants are intended for fixation of fractures, non-unions, arthrodesis and osteotomies of the small bones in the hand and foot. The implants and guide wires are intended for single use only.

    Reason

    The cannulation of the 3.0/4.0 Cannulated Drill Bit inner diamter is too small to allow for the guide wire to pass completely through.

    Code Info

    Lot 1363-01

    Distribution

    Nationwide Distribution including NY, TX, OH, IN, FL, NH, MN, SC, OK, NJ, CA, NC, MO, GA, WI, IA, TN, WA, and Puerto Rico.

    Quantity

    121 units