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Brius Technologies Inc. recalls Brius Pontics (components in a set of custom metal orthodontic devices);BRIUS , RX Only, Non-Sterile, Custom Made Device
Recalled April 13, 2022 · FDA recall Z-0888-2022 · Brius Technologies
Hazard
Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released. · FDA Class II
Units
6
Sold at
US Nationwide: CA, DC, MA, NJ, NY, TX
Description
Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.
Product
Brius Pontics (components in a set of custom metal orthodontic devices);BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL
Manufacturer(s)
Brius Technologies Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →