BEUDAMED
    FDA Recall Terminated

    Blackstone Medical Inc./ Orthofix Spinal Implants, Hallmark Anterior Cervical Plate System; Plate Bender Part number 62-0070. Non Sterile.

    Recall: Z-1653-2010 · Initiated March 15, 2010

    Recall

    Recall Number
    Z-1653-2010
    Event Number
    55002
    Firm
    Blackstone Medical, Inc.
    FEI Number
    3001238051
    Product Code
    KWQ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 15, 2010
    Posted
    May 26, 2010
    Terminated
    September 9, 2011
    Address
    1211 Hamburg Tpke, Suite 300, Wayne, NJ, 07470

    Description

    Blackstone Medical Inc./ Orthofix Spinal Implants, Hallmark Anterior Cervical Plate System; Plate Bender Part number 62-0070. Non Sterile.

    Reason

    The Hallmark Anterior Cervical Plate Bender may have a non conformity causing difficulty accepting 3-4 level plates or to not accept 3-4 level plates that are intended to be additionally contoured.

    Action

    Orthofix send letters of notification of planned product removal to distributors who keep the instrumentation set on 3/29/2010 by Fed Ex. Letters of planned product removal explain the reason for the planned removal and the specific product involved. Replacement product will not be available until July 2010, however, the firm elected to notify customers of the potential problem and the date that formal notification and replacement Plate Benders will be available. Letters state that if there is any problem with the Plate Benders, questions can be directed to David Thompson in Marketing at 972-529-3024 or Jose Charvet in Product Development at 973-406-2824.

    Distribution

    Nationwide distribution, including Puerto Rico, and to Australia.

    Quantity

    98 units domestically, 14 units internationally.