Home / Recalls / Brius Technologies Inc. / Z-0889-2022

Z-0889-2022 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: 4

Product 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 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

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