BEUDAMED
    FDA Recall Terminated

    Depuy Mitek Bioknotless Anchor with Ethibond Suture Ref No. 212728

    Recall: Z-0610-06 · Initiated February 17, 2006

    Recall

    Recall Number
    Z-0610-06
    Event Number
    34684
    Firm
    Depuy Mitek, a Johnson & Johnson Co.
    FEI Number
    1221934
    Product Code
    MAI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 17, 2006
    Posted
    March 15, 2006
    Terminated
    June 28, 2006
    Address
    325 Paramount Dr, Raynham, MA, 02767-5199

    Description

    Depuy Mitek Bioknotless Anchor with Ethibond Suture Ref No. 212728

    Reason

    The inserter shafts bend, as they were manufactured with a different stainless steel than specified.

    Action

    Depuy Mitek notified consignees by letter dated 2/17/06 to request accounts return devices.

    Distribution

    Nationwide

    Quantity

    200 pieces