medical Class II Updated 2022-04-13

Brius Technologies Inc. recalls Brius Pontics (components in a set of custom metal orthodont

Recalled Product

Brius Pontics (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: 524947 .00BB (upper); 524925 .00BB (upper); 524503 .10Bn (upper); 523431 .20U; 524304 .10Bn (upper); 523595 .21bn (upper)
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