BEUDAMED
    FDA Recall 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 · Initiated May 10, 2008

    Recall

    Recall Number
    Z-1482-2013
    Event Number
    64991
    Firm
    SpineFrontier, Inc.
    FEI Number
    3005977257
    Product Code
    HWA
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    May 10, 2008
    Posted
    June 5, 2013
    Terminated
    October 8, 2014
    Address
    500 Cummings Ctr, Ste 3500, Beverly, MA, 01915-6516

    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.

    Action

    Firm states they notified consignees of recall between 5/10/08 and 5/22/2008. Zero product is currently in distribution.

    Distribution

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

    Quantity

    10