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Brius Technologies Recalls
3 recalls on record · April 13, 2022 to April 13, 2022 · Medical Devices
April 13, 2022Medical DevicesFDA
Brius Technologies Inc. recalls Customized Brius Appliances (custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 5
Hazard: Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.
April 13, 2022Medical DevicesFDA
Brius Technologies Inc. recalls Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile,
Hazard: Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.
April 13, 2022Medical DevicesFDA
Brius Technologies Inc. recalls Brius Pontics (components in a set of custom metal orthodontic devices);BRIUS , RX Only, Non-Sterile, Custom Made Device
Hazard: Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.