BEUDAMED
    FDA Recall 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 · Initiated November 19, 2013

    Recall

    Recall Number
    Z-0481-2014
    Event Number
    66978
    Firm
    Ultradent Products, Inc.
    FEI Number
    1718912
    Product Code
    NJM
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 19, 2013
    Posted
    December 11, 2013
    Terminated
    October 6, 2014
    Address
    505 W 10200 S, South Jordan, UT, 84095-3935

    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.

    Action

    Ultradent Products notified consignees via email on November 19, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return all unused product. Sales representatives will pick up remaining unplaced brackets or returns will be sent back using pre-paid envelopes back to Ultradent recall coordinator for quarantine. Consignees were asked to complete evaluation forms to be returned by fax to 800-793-5206. For questions regarding this recall call 801-553-4420.

    Distribution

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

    Quantity

    217 units