BEUDAMED
    FDA Recall Terminated

    Grengloo (Unidose Tips), Bracket adhesive and tooth conditioner, Part Number 740-0322, Lot Number 2792584, Ormco Corporation, Glendora, CA 91740

    Recall: Z-0916-2008 · Initiated October 31, 2007

    Recall

    Recall Number
    Z-0916-2008
    Event Number
    46380
    Firm
    Ormco Corporation
    FEI Number
    2016150
    Product Code
    DYH
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    October 31, 2007
    Posted
    April 10, 2008
    Terminated
    March 22, 2012
    Address
    1332 S Lone Hill Ave, Glendora, CA, 91740-5339

    Description

    Grengloo (Unidose Tips), Bracket adhesive and tooth conditioner, Part Number 740-0322, Lot Number 2792584, Ormco Corporation, Glendora, CA 91740

    Reason

    Mislabeled: Product mislabeled with incorrect expiration date. Expiration date labeled as 2010/07 instead of 2009/07.

    Action

    Ormco sent fourteen (14) consignees Urgent Device Recall Notification via U.S. First Class mail on October 31, 2007. There were two (2) additional letters sent to the consignees in France that were translated into French. The consignees were instructed to complete the Return Form and return any affected product in their inventory. Periodic effectiveness checks will be conducted in order to follow up with non-responders. For more information, contact firm at 1-800-854-1741.

    Distribution

    Worldwide Distribution-USA states of IL, NY, LA, CA, NJ, NV and SC and countries of Canada, France and South Africa.

    Quantity

    4 kits (Total US and Internationally)