Brius recalls custom metal orthodontic appliances 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.
Brius is recalling custom metal orthodontic appliances that were made before standard design controls were completed. This could mean the devices aren't safe for use without proper documentation.
The appliances were sold before completing standard design controls, documentation, and release. This means they might not meet safety requirements for use.
Orthodontic patients who received custom metal appliances from Brius Technologies Inc. are affected. Those with incomplete design documentation may be at higher risk.
Check for the product IDs listed in the recall notice: 52345400UL, 523600.40Bn Upper, and other specific model numbers. These devices were custom-made for dental use.
Look for the specific product IDs listed in the recall notice to identify affected devices.
The recall states that these appliances were made before standard design controls were completed, so they may not be safe without proper documentation.
Check for the specific product IDs listed in the recall notice: 52345400UL, 523600.40Bn Upper, and other model numbers.
The recall does not specify a remedy, so contact Brius Technologies Inc. for further instructions.
We’ve drafted a message you can send Brius to request your refund or repair — edit it as you like.
Subject: Recall Z-0890-2022 — Brius Brius Hello, I own a Brius that is covered by recall Z-0890-2022 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.
