BEUDAMED
    FDA Recall Terminated

    Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Usage: Bracket Buccal Tubes are intended to hold in orthodontic wires used to move teeth during orthodontic treatment

    Recall: Z-1084-2013 · Initiated March 8, 2013

    Recall

    Recall Number
    Z-1084-2013
    Event Number
    64749
    Firm
    Ormco/Sybronendo
    FEI Number
    2016150
    Product Code
    DZD
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    March 8, 2013
    Posted
    April 10, 2013
    Terminated
    September 4, 2013
    Address
    1332 S Lone Hill Ave, Glendora, CA, 91740-5339

    Description

    Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Usage: Bracket Buccal Tubes are intended to hold in orthodontic wires used to move teeth during orthodontic treatment

    Reason

    Ormco Corporation is voluntarily recalling one (1) lot of Bracket Buccal Tubes as a result of a packaging error. More specifically, the Bracket Buccal Tubes product package correctly identifies the product as gingival (0) offset brackets, but actually contains distal (10) offset brackets. Use of the affected product may cause unintended rotation of the molars. Although reversible, a delay in

    Action

    Ormco sent an Urgent Medical Device Recall letter dated March 8, 2013 to all affected customers, via USPS 1st class mail. The letter identified the affected product, problem and actions to be taken. The consignees were instructed to complete the Return Form and return any affected product identified in stock. For questions contact Ormco Customer Care.

    Distribution

    Worldwide Distribution - USA (nationwide) including the country of EU.

    Quantity

    8210