BEUDAMED
    FDA Enforcement Class III Terminated

    The brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic bracket. Part Number 494-4491, Description -Damon 3MX Bicuspid Bracket, Lot Number - 011265039 Product Usage: Damon 3MX Bicuspid Brackets are intended to be a fixed attachment on a tooth which holds an archwire during orthodontic treatment.

    Recall: Z-0120-2013 · Reported October 31, 2012

    Enforcement

    Recall Number
    Z-0120-2013
    Event ID
    63296
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ormco/Sybronendo
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 31, 2012
    Initiation Date
    April 24, 2012
    Classification Date
    October 23, 2012
    Termination Date
    December 12, 2012
    Address
    1332 S Lone Hill Ave, N/A, Glendora, CA, 91740-5339, United States

    Description

    The brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic bracket. Part Number 494-4491, Description -Damon 3MX Bicuspid Bracket, Lot Number - 011265039 Product Usage: Damon 3MX Bicuspid Brackets are intended to be a fixed attachment on a tooth which holds an archwire during orthodontic treatment.

    Reason

    The firm initiated the recall as a result of a misidentification of the brackets. Damon 3MX Bicuspid Brackets are produced with a purple colored ID dot to identify them as maxillary bicuspid brackets; however the affected lot of product listed below was produced with dark blue colored ID dots, which identified them as maxillary central incisor brackets.

    Code Info

    Part Number 494-4491, Description -Damon 3MX Bicuspid Bracket, Lot Number - 011265039

    Distribution

    Worldwide Distribution - US Nationwide and the countries of Canada, China, Costa Rica, Ecuador, French Polynesia, India, Kuwait, Malaysia, Philippines, Singapore, South Korea, Thailand and UAE.

    Quantity

    148