BEUDAMED
    FDA Enforcement Class II Terminated

    Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL

    Recall: Z-0889-2022 · Reported April 13, 2022

    Enforcement

    Recall Number
    Z-0889-2022
    Event ID
    89569
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Brius Technologies Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 13, 2022
    Initiation Date
    February 7, 2022
    Classification Date
    April 7, 2022
    Termination Date
    October 18, 2024
    Address
    2611 Westgrove Dr, Carrollton, TX, 75006-2349, United States

    Description

    Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL

    Reason

    Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.

    Code Info

    523758 .00nB, 523798 .00BB; 523918 .00BB; 523570 .00BB

    Distribution

    US Nationwide: CA, DC, MA, NJ, NY, TX

    Quantity

    4