BEUDAMED
    FDA Enforcement Class III Terminated

    Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use in orthodontic treatment.

    Recall: Z-0481-2014 · Reported December 18, 2013

    Enforcement

    Recall Number
    Z-0481-2014
    Event ID
    66978
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ultradent Products, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 18, 2013
    Initiation Date
    November 19, 2013
    Classification Date
    December 11, 2013
    Termination Date
    October 6, 2014
    Address
    505 W 10200 S, South Jordan, UT, 84095-3935, United States

    Description

    Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets Avex CX2 ceramic brackets are intended for use in orthodontic treatment.

    Reason

    Ultradent Products Inc. is recalling various lots of Avex CX2 Orthodontic Brackets because the design control process was not complete prior to distribution.

    Code Info

    R&D Lot Numbers:4519 - 4522, 4524 - 4527, 4530 - 4534, 4537 - 4548, 4550 - 4554, 4558 - 4612, 4618 - 4624

    Distribution

    Nationwide Distribution including UT, CA, WA, VA, OH, and TN.

    Quantity

    217 units