Brius Technologies Inc.: Medical Device Recall in 2022 - (Recall #: Z-0890-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 7, 2022

Date Posted: April 13, 2022

Recall Number: Z-0890-2022

Event ID: 89569

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.

Status: Terminated

Product Quantity: 13

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated