Z-0890-2022 Class II Terminated
FDA device recall Z-0890-2022 was initiated by Brius Technologies Inc. on February 7, 2022 and is designated Class II. 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. The recall status is terminated (terminated October 18, 2024). Affected quantity: 13.
Recall Details
- Product Type
- Devices
- Report Date
- April 13, 2022
- Initiation Date
- February 7, 2022
- Termination Date
- October 18, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13
Product Description
Customized Brius Appliances (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.
Distribution Pattern
US Nationwide: CA, DC, MA, NJ, NY, TX
Code Information
523600 .40Bn Upper; 523738 .20BB Upper; 523927 .20Bn Upper; 524181 .01bl Lower; 524284 00U Upper; 524284 .01bn Upper; 524490 .02bn Upper; 524896 .00BB Upper; 525258 .00Bn Upper; 523431 .20U; 523431 .30U, 523431 .50U, 523431 .70U