BEUDAMED
    FDA Recall Terminated

    Tiger Cannulated Tray Lid Part # 210-00-001-1 NON-STERILE; Combined Tiger/Headless Screw Part # 210-99-101 NON-STERILE; These are components of the Tiger Cannulated Screw System and the Tiger Headless Cannulated Screw System The Tiger Cannulated Screw Fixation System and the Tiger Headless 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-2464-2015 · Initiated July 20, 2015

    Recall

    Recall Number
    Z-2464-2015
    Event Number
    71813
    Firm
    Trilliant Surgical Ltd.
    FEI Number
    3007420745
    Product Code
    HWC
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    July 20, 2015
    Posted
    August 26, 2015
    Terminated
    January 26, 2017
    Address
    6721 Portwest Dr, Ste 160, Houston, TX, 77024-8019

    Description

    Tiger Cannulated Tray Lid Part # 210-00-001-1 NON-STERILE; Combined Tiger/Headless Screw Part # 210-99-101 NON-STERILE; These are components of the Tiger Cannulated Screw System and the Tiger Headless Cannulated Screw System The Tiger Cannulated Screw Fixation System and the Tiger Headless 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

    Sterilization tray lids for the Tiger and Tiger Headless Cannulated Screw Systems were reported to occasionally be difficult to remove from the sterilization tray.

    Action

    Trilliant sent an Important Medical Device Adivsory Notice dated November 6, 2013, to all affected customers. The letter instructed customers that they have the option of exchanging affected instruments for trays that meet specification at no charge. To initiate the exchange, customers were instructed to contact their local Trilliant Surgical sales representative or the Customer Service Department directly at 1-800-495-2919, or via email at [email protected].

    Distribution

    Nationwide Distribution

    Quantity

    71 units