BEUDAMED
    FDA Enforcement Class II Terminated

    Customized Brius Appliances (custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL

    Recall: Z-0890-2022 · Reported April 13, 2022

    Enforcement

    Recall Number
    Z-0890-2022
    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

    Customized Brius Appliances (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

    523600 .40Bn Upper; 523738 .20BB Upper; 523927 .20Bn Upper; 524181 .01bl Lower; 524284 00U Upper; 524284 .01bn Upper; 524490 .02bn Upper; 524896 .00BB Upper; 525258 .00Bn Upper; 523431 .20U; 523431 .30U, 523431 .50U, 523431 .70U

    Distribution

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

    Quantity

    13