Brius recalls custom metal orthodontic devices made before standard design controls were completed. These devices may not be safe for use without proper documentation.
Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.
Bri:us Technologies recalls custom metal orthodontic devices that were made before completing standard design controls. This could mean the devices aren't safe for use without proper documentation.
The devices were sold before standard design controls were completed and documented. This means they may not meet safety requirements for use in orthodontic treatment.
Orthodontists and patients who purchased custom metal orthodontic devices from Brius Technologies Inc. are affected. Those with the specific device IDs listed are most at risk.
Check for device IDs: 52345400UL, 524947.00BB (upper), 524925.00BB (upper), 524503.10Bn (upper), 523431.20U, 524304.10Bn (upper), 523595.21bn (upper). These are custom metal orthodontic devices made by Brius Technologies Inc.
Look for the specific device IDs listed in the recall notice to confirm if your device is affected.
The devices were sold before completing standard design controls and documentation, which may affect their safety for use.
The recall notice does not specify any action steps beyond checking the device ID.
The recall notice does not describe specific risks, so the danger level is unknown.
We’ve drafted a message you can send Brius to request your refund or repair — edit it as you like.
Subject: Recall Z-0888-2022 — Brius Brius Hello, I own a Brius that is covered by recall Z-0888-2022 from Brius. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
