🔍 RecallPedia

Brius Pontics (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:
    524947 .00BB (upper); 524925 .00BB (upper); 524503 .10Bn (upper); 523431 .20U; 524304 .10Bn (upper); 523595 .21bn (upper)
  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 Pontics (components in a set of custom metal orthodontic devices);BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL

Product Codes/Lot Numbers:

524947 .00BB (upper); 524925 .00BB (upper); 524503 .10Bn (upper); 523431 .20U; 524304 .10Bn (upper); 523595 .21bn (upper)

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0888-2022

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