BEUDAMED
    FDA Recall 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 · Initiated May 9, 2012

    Recall

    Recall Number
    Z-1957-2013
    Event Number
    64994
    Firm
    SpineFrontier, Inc.
    FEI Number
    3005977257
    Product Code
    HXX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 9, 2012
    Posted
    August 13, 2013
    Terminated
    January 10, 2014
    Address
    500 Cummings Ctr, Ste 3500, Beverly, MA, 01915-6516

    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.

    Action

    On May 9, 2012 an email was sent to consignees requesting that the product be returned for servicing and that a replacement part would be sent.

    Distribution

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

    Quantity

    9