BEUDAMED
    FDA Recall Terminated

    BD Beaver Arthro-Lok Pointed Tip 4mm Blade, REF 376780. Becton Dickinson and Company, Waltham, MA 02454. Intended for use in arthroscopic procedures.

    Recall: Z-1638-2010 · Initiated June 12, 2009

    Recall

    Recall Number
    Z-1638-2010
    Event Number
    52291
    Firm
    Becton Dickinson and Company
    FEI Number
    1211998
    Product Code
    HTS
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    June 12, 2009
    Posted
    May 21, 2010
    Terminated
    January 26, 2012
    Address
    411 Waverley Oaks Rd, Ste 2229, Waltham, MA, 02452-8448

    Description

    BD Beaver Arthro-Lok Pointed Tip 4mm Blade, REF 376780. Becton Dickinson and Company, Waltham, MA 02454. Intended for use in arthroscopic procedures.

    Reason

    Mislabeled: Arthro-Lok Pointed Tip 4mm Blade curving right instead of left.

    Action

    Becton Dickinson issued an "Urgent: Field Safety Notice" beginning June 25, 2009 by telephone and letter fax to remove and discard affected product from their possession. Customer verification responses were requested. For further information, contact Becton Dickinson and Company at 1-781-906-7900.

    Distribution

    Worldwide Distribution -- United States, Japan and Belgium.

    Quantity

    354 units