BEUDAMED
    FDA Enforcement Class II Terminated

    Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 501(k) clearance number K121060. The Invue Driver is an instrument consisting of a Radel handle, a shaft and hexalobe-like tip with a 4.0mm split, which allows the driver to collapse to fit into a screw and expand to retain the screw.

    Recall: Z-1927-2013 · Reported August 14, 2013

    Enforcement

    Recall Number
    Z-1927-2013
    Event ID
    65444
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    SpineFrontier, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 14, 2013
    Initiation Date
    May 10, 2013
    Classification Date
    August 8, 2013
    Termination Date
    July 20, 2015
    Address
    500 Cummings Ctr Ste 3500, N/A, Beverly, MA, 01915-6516, United States

    Description

    Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 501(k) clearance number K121060. The Invue Driver is an instrument consisting of a Radel handle, a shaft and hexalobe-like tip with a 4.0mm split, which allows the driver to collapse to fit into a screw and expand to retain the screw.

    Reason

    Device design.

    Code Info

    Lot/Serial Numbers: 027104, 027105

    Distribution

    Nationwide Distribution including Texas, Ohio, and Missouri.

    Quantity

    12 devices