Recall archive / FDA device enforcement
Customized Brius Appliances (custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID:... — FDA record Z-0890-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 7, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Customized Brius Appliances (custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL
- Reason
- Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.
- Classification
- Class II
- Recalling firm
- Brius Technologies Inc.
- Quantity
- 13
- Agency-reported status
- Terminated
- Source record identifier
- Z-0890-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide: CA, DC, MA, NJ, NY, TX
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Apr 13, 2022
- Recall initiation date
- Feb 7, 2022
- Center classification date
- Apr 7, 2022
- Termination date
- Oct 18, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.