CLASS II Device recall · Reported 13 Apr 2022 · FDA Enforcement Report
Brius Patient Specific Brackets (components recalled
Brius Technologies is recalling Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices), distributed nationwide in the US. The recall was initiated on 7 Feb 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0889-2022
- FDA event ID
- 89569
- Recalling firm
- Brius Technologies, Carrollton, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Feb 2022
- FDA classified
- 7 Apr 2022
- Reported
- 13 Apr 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Dental Devices
Timeline
| 7 Feb 2022 | Recall initiated by company | |
| 7 Apr 2022 | Classified by FDA | +59 days |
| 13 Apr 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL
Where it was distributed
US Nationwide: CA, DC, MA, NJ, NY, TX
Nationwide CaliforniaDistrict of ColumbiaMassachusettsNew JerseyNew YorkTexas
Questions about this recall
Is Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices) recalled?
Yes. Brius Technologies recalled Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices) on 7 Feb 2022. The recall is Class II and its status is Terminated. Recall number Z-0889-2022.
Why was it recalled?
Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.
Which lots are affected?
523758 .00nB, 523798 .00BB; 523918 .00BB; 523570 .00BB
Where was it sold?
US Nationwide: CA, DC, MA, NJ, NY, TX
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Brius Technologies
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Brius Pontics (components in a set of custom metal recalled | Brius Technologies | Foreign Material | Nationwide |
| Device | CLASS II | Customized Brius Appliances (custom metal orthodontic devices) recalled | Brius Technologies | Foreign Material | Nationwide |
Other Dental Devices recalls
All 426| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Grandio Universal Nano-Hybrid Restorative Material recalled | Henry Schein | Packaging Defects | Nationwide |
| Device | CLASS II | GM Helix Implant, Endosseous Dental Implant Article No. recalled | Straumann USA | Packaging Defects | Nationwide |
| Device | CLASS II | KL Owen Custom Orthodontic Solution recalled by Klowen Braces | Klowen Braces | Device Malfunction | Nationwide |
| Device | CLASS II | Straumann n!ce PMMA Full-arch Restoration recalled | Straumann USA | Other | 8 states |
| Device | CLASS II | Straumann n!ce Zr, HT, Full-arch Restoration recalled | Straumann USA | Other | 8 states |