Home / Recalls / Brius Technologies Inc. / Z-0888-2022

Z-0888-2022 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: 6

Product Description

Brius Pontics (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

524947 .00BB (upper); 524925 .00BB (upper); 524503 .10Bn (upper); 523431 .20U; 524304 .10Bn (upper); 523595 .21bn (upper)