Brius Patient Brackets Recall: Custom Orthodontic Devices Not Fully Tested
Brius recalls custom orthodontic brackets sold without completing standard design controls. These devices may not be safe for use until proper testing is done.
Lower-risk recall
Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.
Contact the company
What happened, in plain English
Brius is recalling custom metal orthodontic brackets that were sold before completing standard safety testing. This could mean the brackets might not be safe for use until proper testing is done. Read more at govinfonow.com/recall/61174-brius-patient-brackets-recall-custom-orthodontic-devices-not-fully-tested.
Source Summary by GovInfoNow · govinfonow.com/recall/61174-brius-patient-brackets-recall-custom-orthodontic-devices-not-fully-tested · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0889-2022
Cite this page
“Brius Patient Brackets Recall: Custom Orthodontic Devices Not Fully Tested.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61174-brius-patient-brackets-recall-custom-orthodontic-devices-not-fully-tested. Based on FDA recall #Z-0889-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0889-2022%22&limit=1).
Why it’s dangerous
The brackets were sold without completing the standard design control process and documentation required for safety. This means they might not meet safety standards before being released to patients.
Who’s affected
Orthodontists and patients who purchased these custom brackets for dental treatment. Those with active orthodontic procedures using these brackets are most at risk.
How to tell if you have this one
Look for the product ID numbers: 52345400UL, 523758.00nB, 523798.00BB, 523918.00BB, or 523570.00BB. These brackets are custom-made for dental use and require a prescription.
- Brand
Brius- Category
Medical device
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
US Nationwide: CA, DC, MA, NJ, NY, TX
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0888-2022 | Brius Pontics (components in a set of custom metal orthodontic devices);BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL; 524947 .00BB (upper); 524925 .00BB (upper); 524503 .10Bn (upper); 523431 .20U; 524304 .10Bn (upper); 523595 .21bn (upper) | 6 |
| Z-0889-2022 | Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL; 523758 .00nB, 523798 .00BB; 523918 .00BB; 523570 .00BB | 4 |
| Z-0890-2022 | Customized Brius Appliances (custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL; 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 | 13 |
What to do — step by step
Check Product ID
Look for the specific ID numbers listed in the recall notice to confirm if your brackets are affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 5 states.
FDA distribution: “US Nationwide: CA, DC, MA, NJ, NY, TX” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, District of Columbia, Massachusetts, New Jersey, New York, Texas.
Recall timeline
FDA terminated this recall 2.7 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0889-2022 (February 7, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0889-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.