BEUDAMED
    FDA Recall 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 · Initiated January 13, 2017

    Recall

    Recall Number
    Z-1151-2017
    Event Number
    76275
    Firm
    Vertebral Technologies, Inc.
    FEI Number
    3007617183
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 13, 2017
    Terminated
    October 5, 2017
    Address
    13845 Industrial Park Blvd, Minneapolis, MN, 55441-3746

    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.

    Action

    Consignees were sent via email a VTI "Advisory Notice" letter. The letter listed the Concern, Impact, Alternate Methods, Affected Lots, and Your Responsibility. Consignees were requested to acknowledge receipt of this notice, Discontinue use of the Tail Traction Tool when implanting the InterFuse T tailed implant, Notify individuals that may potentially use the device and alternate module assembly methods. Advise consignees to contact Customer Service (1-877-912-5401 in US , +-952-912-5400 outside US or [email protected] to obtain a replacement instrument.

    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