Brius Pontics 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 Pontics (components in a set of custom metal orthodontic devices);BRIUS , RX Only, Non-Sterile, Custom Made Devic…
- Recall number
- Z-0888-2022
- 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 Pontics (components in a set of custom metal orthodontic devices);BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL
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