Customized Brius orthodontic devices recalled for design control failure
Brius Technologies is recalling 13 customized metal orthodontic appliances that were sold and distributed prior to completing the required design control process 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall involving products released without completing required design control and documentation. No illnesses or injuries have been reported, but unvalidated design represents a risk-of-harm situation for patients using these customized orthodontic appliances.
Plain-English summary
Brius Technologies Inc. is recalling customized Brius metal orthodontic appliances, including brackets and pontics. These devices were sold and distributed prior to completing the standard design control process and required documentation.
The recall affects 13 customized devices with various product codes, distributed to California, DC, Massachusetts, New Jersey, New York, and Texas. The devices are prescription-only, non-sterile, custom-made products.
Patients who received these customized orthodontic appliances should contact their orthodontist or dental care provider to determine if their specific device is included in this recall. Healthcare providers should consult with Brius Technologies Inc. for guidance on appropriate follow-up actions.
The recalled product
- Product
- Customized Brius Appliances (custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL
- Manufacturer
- Brius Technologies Inc.
- Category
- Medical Device — Orthodontic
- Hazard
- Affected units
- 13
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 (13)
- 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
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
- ModerateBrius Pontics Orthodontic Devices Recalled for Incomplete Design Validation
FDA (Devices) · 2022-04-13
Same hazard · design control failure
See all →- ModerateSCM True Air Technologies Recalls MaXair Mattress Replacement Systems
FDA (Devices) · 2014-05-28
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