Z-0888-2022 Class II Terminated
FDA device recall Z-0888-2022 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: 6.
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
- 6
Product Description
Brius Pontics (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.
Distribution Pattern
US Nationwide: CA, DC, MA, NJ, NY, TX
Code Information
524947 .00BB (upper); 524925 .00BB (upper); 524503 .10Bn (upper); 523431 .20U; 524304 .10Bn (upper); 523595 .21bn (upper)