BEUDAMED
    FDA Enforcement Class II 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 · Reported July 8, 2020

    Enforcement

    Recall Number
    Z-2478-2020
    Event ID
    85468
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ortho Organizers, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 8, 2020
    Initiation Date
    April 2, 2019
    Classification Date
    June 30, 2020
    Termination Date
    March 24, 2022
    Address
    1822 Aston Ave, N/A, Carlsbad, CA, 92008-7306, United States

    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

    Code Info

    Maestro Orthodontic Bracket ,.018 Kit U/L SxS P/N711-298Q (01)00190707017064 (10)889437 (422)484 Lot# 878285 Maestro Orthodontic Bracket .018 Kit U/L SxS MC Hooks P/N711-299MCQ UDI (01)00190707017071(10)889437 (422)484 Lot#872900

    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