BEUDAMED
    FDA Enforcement Class II Terminated

    Invue Solid Driver, Tipped, AO. Part Number: 11-70083. Allows the user to retain the screw when changing axis of insertion during fixation of spinal intervertebral.

    Recall: Z-1957-2013 · Reported August 21, 2013

    Enforcement

    Recall Number
    Z-1957-2013
    Event ID
    64994
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    SpineFrontier, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 21, 2013
    Initiation Date
    May 9, 2012
    Classification Date
    August 13, 2013
    Termination Date
    January 10, 2014
    Address
    500 Cummings Ctr Ste 3500, Beverly, MA, 01915-6516, United States

    Description

    Invue Solid Driver, Tipped, AO. Part Number: 11-70083. Allows the user to retain the screw when changing axis of insertion during fixation of spinal intervertebral.

    Reason

    The nipple of the tipped driver broke off when surgeons were attempting to insert the screw.

    Code Info

    Lot Number: 011836-0001, 011981-001

    Distribution

    Distributed in DC and the states of MA, and OK.

    Quantity

    9