BEUDAMED
    FDA Enforcement Class II Terminated

    InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly Product Usage: Inserters are stainless steel instruments that have an inner shaft. The left and right inserters are used in combination with each other to place the implants into the body. Inserters are used to install the InSpan Spinous Plate System for the purpose of achieving supplemental fixation.

    Recall: Z-1666-2013 · Reported July 10, 2013

    Enforcement

    Recall Number
    Z-1666-2013
    Event ID
    65442
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    SpineFrontier, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    July 10, 2013
    Initiation Date
    May 7, 2013
    Classification Date
    July 4, 2013
    Termination Date
    January 11, 2016
    Address
    500 Cummings Ctr Ste 3500, N/A, Beverly, MA, 01915-6516, United States

    Description

    InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly Product Usage: Inserters are stainless steel instruments that have an inner shaft. The left and right inserters are used in combination with each other to place the implants into the body. Inserters are used to install the InSpan Spinous Plate System for the purpose of achieving supplemental fixation.

    Reason

    Potential for set screw to be come deformed.

    Code Info

    Right Assembly: 43097, 44614, 43097R; Left Assembly: 43098, 44615, 43098R

    Distribution

    Worldwide Distribution - USA Nationwide: in the states of: FL, CO, VA, KS, TX, OH, TN, OK, CA, IL, MO, MN, Wash DC, including PR and the countries of Dominican Republic, Medico, Panama

    Quantity

    61 individual inserter assemblies