🔍 RecallPedia

BioMend Extend, REF# 0142Z, Synthetic bone grafting material.

Class I - Dangerous
🏥 Medical Devices Recalled: August 16, 2018 Collagen Matrix Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    CDMEN18F1, CDMEN18F3
  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:
Collagen Matrix, Inc.
Reason for Recall:
There is a possibility that the product was packaged in the wrong box. Specifically, the product may have been placed inside a BioMend box instead of a BioMend Extend box. The only difference between the two boxes is the product trade name. The label placed on the box and on the product packaged inside the box is correct. The Instructions for Use inside the box are correct.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

BioMend Extend, REF# 0142Z, Synthetic bone grafting material.

Product Codes/Lot Numbers:

CDMEN18F1, CDMEN18F3

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0414-2019

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