ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    UDI-DI: 04573190050637. Lots: 25F07104JF, 25F07105JF, 25F07106JF
  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:
Orthorebirth Co Ltd
Reason for Recall:
Resorbable bone void filler falls outside standard specifications.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

ZENBONE, REF: ORB-0320C-Z, ORB-0310C-Z, ORB-0304C-Z

Product Codes/Lot Numbers:

UDI-DI: 04573190050637. Lots: 25F07104JF, 25F07105JF, 25F07106JF

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2132-2026

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