BEUDAMED
    FDA Enforcement Class II 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 · Reported April 17, 2013

    Enforcement

    Recall Number
    Z-1084-2013
    Event ID
    64749
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ormco/Sybronendo
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 17, 2013
    Initiation Date
    March 8, 2013
    Classification Date
    April 10, 2013
    Termination Date
    September 4, 2013
    Address
    1332 S Lone Hill Ave, Glendora, CA, 91740-5339, United States

    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

    Code Info

    Part Number 438-0184 Lot Number 051063597

    Distribution

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

    Quantity

    8210