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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Affected units
- 6
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
Part of a larger recall action
This product is one of 3 recalled by Brius Technologies Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Brius Technologies Inc.
See all →- ModerateBrius Patient Specific Brackets recalled without completing design control process
FDA (Devices) · 2022-04-13
- HighCustomized Brius orthodontic devices recalled for design control failure
FDA (Devices) · 2022-04-13
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