FDA Device recall Z-0889-2022
Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices)
- FDA Device
- Class II
- terminated
- Published 2022-04-13
On 2022-04-13 the FDA classified a Class II recall of Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices) by Brius Technologies, citing pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0889-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-02-07 |
| Published | 2022-04-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Brius Technologies |
| Distribution | US |
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
Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.
Identifiers
| code_info | 523758 .00nB, 523798 .00BB; 523918 .00BB; 523570 .00BB |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0889-2022%22
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