Brius Technologies Inc.: Medical Device Recall in 2022 - (Recall #: Z-0889-2022)

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:

Brius Patient Specific Brackets (components in a set of 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-0889-2022

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: 4

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated