Brius Technologies Inc. Recall 89569
Description: Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL
Brius Technologies Inc. Recall 89569 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0889-2022 |
| Event ID | 89569 |
| Event Description | Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL |
| Product Type | Devices |
| Distribution | US Nationwide: CA, DC, MA, NJ, NY, TX |
| Quantity | 4 |
| Recall Reason | Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released. |
| Device Classification | 20220413 |
| Device Code Info | 523758 .00nB, 523798 .00BB; 523918 .00BB; 523570 .00BB |
| Center Classification Date | 20220407 |
| Recall Initiation Date | 20220207 |
| Recalling Firm | Brius Technologies Inc. |
| Initial Notification | Letter |
| Similar To |