BEUDAMED
    FDA Recall Terminated

    Mitek M. Kurosaka Advantage 7 X 30 mm Cannulated Fixation Screw Product Reference No.: 230030

    Recall: Z-0696-03 · Initiated February 28, 2003

    Recall

    Recall Number
    Z-0696-03
    Event Number
    25698
    Firm
    Mitek Worldwide
    Product Code
    HWC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 28, 2003
    Posted
    April 1, 2003
    Terminated
    February 4, 2004
    Address
    249 Vanderbilt Drive, Norwood, MA, 02062

    Description

    Mitek M. Kurosaka Advantage 7 X 30 mm Cannulated Fixation Screw Product Reference No.: 230030

    Reason

    Mislabeled product: Screw length incorrectly labeled may contain a 20 mm instead of 30 mm.

    Action

    Mitek Worldwide notified domestic accounts by US Mail on 2/28/03. The International affiliates were sent notifications by Federal Express on 2/28/03.

    Distribution

    CO, FL, MN, PA, TX International- Mitek Affiliates: Australia, Columbia, Japan UK,

    Quantity

    4