BEUDAMED
    FDA Recall Terminated

    Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, Tq +13 degrees, Rx. Manufactured by Ormco Corporation, This device is intended for use for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed.

    Recall: Z-2286-2020 · Initiated January 14, 2020

    Recall

    Recall Number
    Z-2286-2020
    Event Number
    85427
    Firm
    Ormco/Sybronendo
    FEI Number
    2016150
    Product Code
    EJF
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 14, 2020
    Terminated
    February 10, 2025
    Address
    1332 S Lone Hill Ave, Glendora, CA, 91740-5339

    Description

    Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, Tq +13 degrees, Rx. Manufactured by Ormco Corporation, This device is intended for use for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed.

    Reason

    The bracket torque was mislabeled on the packaging.

    Action

    The firm, Ormco, sent "URGENT: MEDICAL DEVICE CORRECTION" letters dated 1/6/2020 via USPS on 1/14/2020 to consignees explaining the brackets were mislabeled and the risk associated with using the incorrect bracket. The consignees were requested to call Ormco customer service at 1-800-854-1741 or email: [email protected] to log any complaints related to this issue; assess your patients; over-label the affected product in inventory using the enclosed corrected label and complete the enclosed acknowledgement form and email the form to [email protected] within 10 business days. If you have any questions or require additional information, please contact our customer care department at 800-854-1741, between the hours of 7am to 5pm (PST) or send an email to [email protected].

    Distribution

    Worldwide Distribution: US (nationwide) to states of: AR, AZ, FL, GA, IL, LA, MS, NC, NE, NJ, NY, PA, TN, and TX. Foreign distribution was made to Belgium, Czech Republic, France, Germany, Israel, Italy, Kuwait, Latvia, Lebanon, Norway, Poland, Portugal, Saudi Arabia, Slovakia, South Africa, Spain, Switzerland, Tunisia, United Arab Emirates, and United Kingdom.

    Quantity

    2,189 units