Home / Recalls / Medical Devices
Brius Technologies Inc. recalls Customized Brius Appliances (custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 5
Recalled April 13, 2022 · FDA recall Z-0890-2022 · 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
13
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
Customized Brius Appliances (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 →