BEUDAMED
    FDA Enforcement Class III Terminated

    Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017, Product Usage: Avex CX ceramic brackets are formed with 99.9% pure alumina oxide. The indicated use of the Avex CX ceramic bracket is the mechanical movement of natural teeth in conjunction with other components designed to attach to the brackets.

    Recall: Z-0876-2013 · Reported March 6, 2013

    Enforcement

    Recall Number
    Z-0876-2013
    Event ID
    64303
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ultradent Products, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 6, 2013
    Initiation Date
    February 8, 2013
    Classification Date
    February 22, 2013
    Termination Date
    June 7, 2013
    Address
    505 W 10200 S, N/A, South Jordan, UT, 84095-3935, United States

    Description

    Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017, Product Usage: Avex CX ceramic brackets are formed with 99.9% pure alumina oxide. The indicated use of the Avex CX ceramic bracket is the mechanical movement of natural teeth in conjunction with other components designed to attach to the brackets.

    Reason

    Orthodontic brackets distributed was incorrectly labeled.

    Code Info

    Lot R131360

    Distribution

    USA Nationwide Distribution including the states of CA, AZ, CO and WA.

    Quantity

    124