BEUDAMED
    FDA Enforcement Class II Terminated

    BASE, S-LIFT Instrument Case Product Usage: System cases are designed to hold and secure all instrumentation to be used with a surgical system. Case and caddy components are used to contain implants intended for intervertebral body fusion and fixation of the spine.

    Recall: Z-1664-2013 · Reported July 10, 2013

    Enforcement

    Recall Number
    Z-1664-2013
    Event ID
    65432
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    SpineFrontier, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 10, 2013
    Initiation Date
    May 17, 2013
    Classification Date
    July 4, 2013
    Termination Date
    May 17, 2016
    Address
    500 Cummings Ctr Ste 3500, N/A, Beverly, MA, 01915-6516, United States

    Description

    BASE, S-LIFT Instrument Case Product Usage: System cases are designed to hold and secure all instrumentation to be used with a surgical system. Case and caddy components are used to contain implants intended for intervertebral body fusion and fixation of the spine.

    Reason

    The S-LIFT Instrument Case contained a bracket with peeling nylon coating.

    Code Info

    Lot/Serial Numbers: 7201.007 and 7201.007-1

    Distribution

    USA Nationwide including the states of: FL, CO, Wash DC, VA, KS, TX, OH, TN, OK, CA, IL, MO, and MN.

    Quantity

    12