Reported Apr 13, 2022 · Terminated
Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only,…
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?
- Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device
- ID52345400UL
- Lot codes and dates
523758 .00nB523798 .00BB523918 .00BB523570 .00BB
- Amount recalled
- 4
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
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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