Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL
Reported: April 13, 2022 Initiated: February 7, 2022 #Z-0889-2022
Product Description
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.
Details
- Recalling Firm
- Brius Technologies Inc.
- Units Affected
- 4
- Distribution
- US Nationwide: CA, DC, MA, NJ, NY, TX
- Location
- Carrollton, TX
Frequently Asked Questions
What product was recalled? ▼
Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL. Recalled by Brius Technologies Inc.. Units affected: 4.
Why was this product recalled? ▼
Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 13, 2022. Severity: Moderate. Recall number: Z-0889-2022.
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