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Recall Observatory FDA recall evidence

Device product

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

Z-0888-2022

February 07, 2022

Class II

Product summary

Firm
Brius Technologies Inc.
Event
Event 89569
Status
Terminated
Classification
Class II
Quantity
6
Official record key
device-enforcement:Z-0888-2022

Official wording

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

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

Distribution pattern: US Nationwide: CA, DC, MA, NJ, NY, TX

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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