🔍 RecallPedia

Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL

Class I - Dangerous
🏥 Medical Devices Recalled: February 7, 2022 Brius Technologies Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    523758 .00nB, 523798 .00BB; 523918 .00BB; 523570 .00BB
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Brius Technologies Inc.
Reason for Recall:
Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL

Product Codes/Lot Numbers:

523758 .00nB, 523798 .00BB; 523918 .00BB; 523570 .00BB

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0889-2022

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