Reported Apr 13, 2022 · Terminated

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

Brius Technologies Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Brius Technologies Inc. · 2611 Westgrove Dr · Carrollton, TX · 75006-2349

Is this the product you have?

Customized Brius Appliances (custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device
ID52345400UL

Lot codes and dates: 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
Amount recalled: 13

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

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.

This product could cause temporary or reversible health problems — stop using it.

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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By hazard

Where it was distributed

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