Home / Recalls / Brius Technologies Inc. / Z-0890-2022

Z-0890-2022 Class II Terminated

Recalled by Brius Technologies Inc. — Carrollton, TX

Recall Details

Product Type: Devices
Report Date: April 13, 2022
Initiation Date: February 7, 2022
Termination Date: October 18, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 13

Product Description

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

Reason for Recall

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

Distribution Pattern

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

Code Information

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