BEUDAMED
    FDA Enforcement Class II Terminated

    2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.0 Cannulated Screw Countersink Part # 210-40-002 NON-STERILE Product Usage: 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-2421-2015 · Reported August 26, 2015

    Enforcement

    Recall Number
    Z-2421-2015
    Event ID
    71783
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Trilliant Surgical Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 26, 2015
    Initiation Date
    July 20, 2015
    Classification Date
    August 19, 2015
    Termination Date
    January 26, 2017
    Address
    6721 Portwest Dr Ste 160, Houston, TX, 77024-8019, United States

    Description

    2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.0 Cannulated Screw Countersink Part # 210-40-002 NON-STERILE Product Usage: 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 cutting efficiency of the Countersinks was out of specification.

    Code Info

    Lot numbers 1362-01 and 1364-01

    Distribution

    US Nationwide Distribution in the states of: NY, CT, TN, TX, OH, IN, LA, NC, MO, MN, GA, FL, SC, WA, WI, IA, PA, CA, ND, OK, NJ, MI and MD.

    Quantity

    102 units