Brius Patient Specific Brackets recalled without completing design control process
Brius Technologies is recalling Brius Patient Specific Brackets that were sold before the company completed the required design control process and regulatory documentation.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall issued for procedural non-compliance. No illnesses or injuries are reported, and the source does not identify a specific defect or safety hazard beyond the incomplete design control process. This meets the criteria for a moderate-severity precautionary recall.
Plain-English summary
Brius Technologies Inc. is recalling Brius Patient Specific Brackets, custom metal orthodontic devices distributed in the United States (California, Washington D.C., Massachusetts, New Jersey, New York, and Texas).
The recall was issued because the devices were distributed prior to completing the standard design control process. FDA regulations require medical device manufacturers to complete this process to ensure proper design, documentation, and release procedures are followed before devices are sold.
Patients who have received these orthodontic brackets should consult with their orthodontist regarding the status of their devices. Healthcare providers and patients with questions or concerns should contact Brius Technologies Inc. or the FDA.
The recalled product
- Product
- Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL
- Manufacturer
- Brius Technologies Inc.
- Category
- Medical Device — Orthodontic
- Hazard
- design-control-failure
- incomplete-validation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- 523758 .00nB
- 523798 .00BB
- 523918 .00BB
- 523570 .00BB
Distribution
Distributed nationwide across the United States.
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