Brius Patient Specific Brackets recalled over sterility concerns

Recall date

February 7, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Brius Technologies Inc. recalls Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile…

Recall number

Z-0889-2022

FDA classification

Class II

Brand / firm

Brius Technologies Inc.

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL