Brius Pontics Orthodontic Devices Recalled for Incomplete Design Validation
Brius Technologies recalls Brius Pontics custom orthodontic devices that were sold before completing required design control procedures and 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: This is a Class II recall with no reported illnesses, injuries, or identified safety hazards. The issue is regulatory non-compliance (incomplete design control and documentation) rather than a known safety defect. Per the rubric, recalls involving procedural violations without reported incidents are scored at the Moderate level.
Plain-English summary
Brius Technologies Inc. is recalling Brius Pontics, custom metal orthodontic devices (pontics, brackets, and related appliances). The devices were distributed prior to completion of the FDA-required design control process and were not fully documented before release.
Design control is a regulatory requirement intended to ensure medical devices are properly validated and safe before distribution. Selling these devices without completing this process constitutes a regulatory non-compliance issue.
Affected devices were distributed nationwide to locations in California, District of Columbia, Massachusetts, New Jersey, New York, and Texas. Patients or dental professionals who possess these devices should contact Brius Technologies Inc. or their dental provider for information about the recall and next steps.
The recalled product
- Product
- Brius Pontics (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-violation
- undocumented-device
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 (6)
- 524947 .00BB (upper)
- 524925 .00BB (upper)
- 524503 .10Bn (upper)
- 523431 .20U
- 524304 .10Bn (upper)
- 523595 .21bn (upper)
Distribution
Distributed nationwide across the United States.
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