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FDAFebruary 7, 2022device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

brius technologiesbrius

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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