BEUDAMED
    FDA Recall Terminated

    Maestro Orthodontic Bracket REF711-298Q QTY. 20 Rx Only (01)00190707017064 (10)889437 (422)484 Maestro Orthodontic Bracket REF711-299MCQ QTY. 20 Rx Only (01)00190707017071(10)889437 (422)484

    Recall: Z-2478-2020 · Initiated April 2, 2019

    Recall

    Recall Number
    Z-2478-2020
    Event Number
    85468
    Firm
    Ortho Organizers, Inc.
    FEI Number
    2081322
    Product Code
    EJF
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 2, 2019
    Terminated
    March 24, 2022
    Address
    1822 Aston Ave, Carlsbad, CA, 92008-7306

    Description

    Maestro Orthodontic Bracket REF711-298Q QTY. 20 Rx Only (01)00190707017064 (10)889437 (422)484 Maestro Orthodontic Bracket REF711-299MCQ QTY. 20 Rx Only (01)00190707017071(10)889437 (422)484

    Reason

    Orthodontic Bracket is mislabeled

    Action

    The firm notified their consignees of the recall by letter sent out 1st class mail on 4/2/2019. The recall was initiated due to a mislabeling error. The Upper Right bracket was erroneously color coded as an Upper Left brackets and then comingled within the same bag. The firm is asking recipients of affected product to please contact Customer Service at 1-800-547-2000 to receive an RMA number. The RMA will allow for a quick return and replacement or credit. The firm is requesting that distributors and physicians complete and E-mail the acknowledgment form back to the firm in order to confirm receipt of the field correction letter. Additionally they are asking authorized distributor,to identify those customers that may have been shipped the affected product and contact those customers to inform them of the issue within fortyeight (48) hours of receipt of this field correction notification.

    Distribution

    13 US Consignees in FL, GA, CA, MI, ID, TX 1 = Italy 1 = Japan 1 = Greece 1 = Saudi Arabia 1 = Russia 1 = Czech Republic

    Quantity

    147 kits