BEUDAMED
    FDA Enforcement Class II Terminated

    Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O The product is a component of a system indicated for the fixation of fractures, non-unions, arthrodeses, and osteotomies of bones appropriate for the size of the device.

    Recall: Z-0960-2017 · Reported January 18, 2017

    Enforcement

    Recall Number
    Z-0960-2017
    Event ID
    76029
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Trilliant Surgical Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 18, 2017
    Initiation Date
    December 8, 2016
    Classification Date
    January 6, 2017
    Termination Date
    May 17, 2017
    Address
    6721 Portwest Dr Ste 160, Houston, TX, 77024-8019, United States

    Description

    Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O The product is a component of a system indicated for the fixation of fractures, non-unions, arthrodeses, and osteotomies of bones appropriate for the size of the device.

    Reason

    Four lots of Tiger Screw Sterilization Tray Base Assemblies were released to the field with a printing error where k-wire description markings indicate diameters of 0.45 and 0.35 instead of 0.045" and 0.035", respectively.

    Code Info

    Lot: TSL003191, TSL003637, TSL004101, TSL004395

    Distribution

    Nationwide Distribution

    Quantity

    50 units