Carrollton, TX, United States
Brius Technologies Inc. recalls
1 recall recorded since 2018, most recently on 7 February 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 7 February 2022
- Terminated
- 18 October 2024
- Reason
- Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.
- Distribution
- US Nationwide: CA, DC, MA, NJ, NY, TX
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0889-2022, Z-0890-2022, Z-0888-2022
- Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL
- Customized Brius Appliances (custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL
- Brius Pontics (components in a set of custom metal orthodontic devices);BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.