BEUDAMED
    FDA Enforcement Class II Terminated

    lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164

    Recall: Z-0977-2015 · Reported January 21, 2015

    Enforcement

    Recall Number
    Z-0977-2015
    Event ID
    70065
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    SpineFrontier, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 21, 2015
    Initiation Date
    December 19, 2014
    Classification Date
    January 14, 2015
    Termination Date
    January 11, 2016
    Address
    500 Cummings Ctr Ste 3500, Beverly, MA, 01915-6516, United States

    Description

    lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164

    Reason

    A crack may develop in the handle to the Inline Persuader, which may progress if the user continues to use the affected instrument.

    Code Info

    Lot/Serial Numbers: 06440-0000, 06441-0000, AG24

    Distribution

    Nationwide Distribution including TX, OH, VA, and Washington, DC.

    Quantity

    4 devices