BEUDAMED
    FDA Enforcement Class II Terminated

    Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to position implants after they have been inserted into the disc space during implantation of intervertebral body fusion devices.

    Recall: Z-1482-2013 · Reported June 12, 2013

    Enforcement

    Recall Number
    Z-1482-2013
    Event ID
    64991
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    SpineFrontier, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    June 12, 2013
    Initiation Date
    May 10, 2008
    Classification Date
    June 5, 2013
    Termination Date
    October 8, 2014
    Address
    500 Cummings Ctr Ste 3500, N/A, Beverly, MA, 01915-6516, United States

    Description

    Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to position implants after they have been inserted into the disc space during implantation of intervertebral body fusion devices.

    Reason

    During two separate occasions an impactor plate on the handle broke off while being struck by a mallet.

    Code Info

    Lot number: 20856

    Distribution

    Worldwide distribution: US (nationwide) to states of: CO, MA, and TX; and country of: Jamaica.

    Quantity

    10