Brius Patient Specific Brackets — Class II medical device recall Z-0889-2022
Terminated recall by Brius Technologies Inc., reported 2022-04-13, distributed nationwide. Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the sta
| Recall number | Z-0889-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Brius Technologies Inc., Carrollton, TX, United States |
| Recall initiated | 2022-02-07 |
| Classified | 2022-04-07 |
| Reported by FDA | 2022-04-13 |
| Terminated | 2024-10-18 |
| Distributed | Nationwide (US) |
| Quantity | 4 |
Product
Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL
Reason for recall
Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0889-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.