BEUDAMED
    FDA Recall Terminated

    Profile 7 x 25 mm Cannulated Interference Screw Round Head Catalog Number: 230325

    Recall: Z-1004-03 · Initiated June 16, 2003

    Recall

    Recall Number
    Z-1004-03
    Event Number
    26503
    Firm
    Mitek Worldwide
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 16, 2003
    Posted
    July 15, 2003
    Terminated
    October 22, 2003
    Address
    249 Vanderbuilt Drive, Norwood, MA, 02063

    Description

    Profile 7 x 25 mm Cannulated Interference Screw Round Head Catalog Number: 230325

    Reason

    Mislabeled -Incorrect Screw Size. The unit labeled 7x 25 mm screw may be a 8 x2 0 mm; and the unit labeled 8 x20 mm may be a 7 X 25mm

    Action

    Mitek notified consignees by letter on 6/16/0 by US Mail Certified Return Receipt. The international affiliates were notified by email on 6/16/03. Users were requested to return product in inventory.

    Distribution

    CA, FL, NJ, MO, NY, OR, TX, VA Foreign: Argentina, Australia, Japan, Arab Emirates, Portugal, spain

    Quantity

    40