Brius recalls custom orthodontic brackets sold without completing standard design controls. These devices may not be safe for use until proper testing is done.
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 brackets that were sold before completing standard safety testing. This could mean the brackets might not be safe for use until proper testing is done.
The brackets were sold without completing the standard design control process and documentation required for safety. This means they might not meet safety standards before being released to patients.
Orthodontists and patients who purchased these custom brackets for dental treatment. Those with active orthodontic procedures using these brackets are most at risk.
Look for the product ID numbers: 52345400UL, 523758.00nB, 523798.00BB, 523918.00BB, or 523570.00BB. These brackets are custom-made for dental use and require a prescription.
Look for the specific ID numbers listed in the recall notice to confirm if your brackets are affected.
The recall states these brackets were sold before completing standard safety testing, so they may not be safe until proper testing is done.
Check for the product ID numbers: 52345400UL, 523758.00nB, 523798.00BB, 523918.00BB, or 523570.00BB.
The recall does not specify a stop-use instruction, so you can continue using them if you have them, but they should be checked for safety.
We’ve drafted a message you can send Brius to request your refund or repair — edit it as you like.
Subject: Recall Z-0889-2022 — Brius Brius Hello, I own a Brius that is covered by recall Z-0889-2022 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.
