BEUDAMED
    FDA Enforcement Class II Terminated

    VisuALIF,System consisting of a 'U' shaped PEEK block in two footprint configurations, four heights and three lordosis angles., part number: 0301-1410. Intended to be implanted via an open anterior approach.

    Recall: Z-2258-2013 · Reported September 25, 2013

    Enforcement

    Recall Number
    Z-2258-2013
    Event ID
    65999
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Spine Smith Holdings, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    September 25, 2013
    Initiation Date
    July 31, 2013
    Classification Date
    September 19, 2013
    Termination Date
    March 18, 2014
    Address
    93 Red River St, N/A, Austin, TX, 78701-4216, United States

    Description

    VisuALIF,System consisting of a 'U' shaped PEEK block in two footprint configurations, four heights and three lordosis angles., part number: 0301-1410. Intended to be implanted via an open anterior approach.

    Reason

    The product has the potential to be laser marked as a Medium when it actually is a Small.

    Code Info

    Part Number: 0301-1410, Lot 53AR

    Distribution

    Distributed in FL.

    Quantity

    32