Class II — Brius Technologies Inc.
| Recalling firm | Brius |
|---|---|
| Registered facility | BRIUS Technologies Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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 |
| Quantity | 13 |
| Distribution | US Nationwide: CA, DC, MA, NJ, NY, TX |
| Initiated | 2022-02-07 |
| Classified | 2022-04-07 |
| Terminated | 2024-10-18 |
| Recall number | Z-0890-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Brius Technologies Inc. (Z-0890-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89569/
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