medical Class II Updated 2022-04-13

Brius Technologies Inc. recalls Brius Patient Specific Brackets (components in a set of cust

Recalled Product

Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL

Hazard / Issue

Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 523758 .00nB, 523798 .00BB; 523918 .00BB; 523570 .00BB
View official government recall

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