BEUDAMED
    FDA Enforcement Class II Terminated

    InterFuse Tail Traction Tool, Part Number 9116. The InterFuse Tail Traction Tool is an optional Class I non-sterile reusable instrument that can be used to assist with module locking of the InterFuse S or InterFuse T implant system. The system has a modular design to allow the device to be assembled within the disc space to minimize the surgical window, while providing a footprint that approximates the excised nucleus.

    Recall: Z-1151-2017 · Reported February 15, 2017

    Enforcement

    Recall Number
    Z-1151-2017
    Event ID
    76275
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Vertebral Technologies, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 15, 2017
    Initiation Date
    January 13, 2017
    Classification Date
    February 8, 2017
    Termination Date
    October 5, 2017
    Address
    13845 Industrial Park Blvd, N/A, Minneapolis, MN, 55441-3746, United States

    Description

    InterFuse Tail Traction Tool, Part Number 9116. The InterFuse Tail Traction Tool is an optional Class I non-sterile reusable instrument that can be used to assist with module locking of the InterFuse S or InterFuse T implant system. The system has a modular design to allow the device to be assembled within the disc space to minimize the surgical window, while providing a footprint that approximates the excised nucleus.

    Reason

    Fit issues have been identified with the Tail Traction Tool (PN 9116) when used with the Interfuse T tailed implant. The InterFuse T Tail may not fit into the Thru Hole in the instrument.

    Code Info

    Lot: 110512-02, 110718-01, 110831-02, 120214-01, 120403-018, 120420-07, 120711-02, 120911-06

    Distribution

    US: IL, WI, OH, NY, MT, FL, MD, IN, TN, TX, MN. OUS: Italy, Taiwan Spain, Belgium, Canada, Netherlands, Sweden, Switzerland, Portugal, Brazil. Germany, Ireland,

    Quantity

    63 pieces