🔍 RecallPedia

Straumann¿ Emdogain 0.7 ml Multipack. Enamel Matrix Derivative. Article Number 075.116W

Class I - Dangerous
🏥 Medical Devices Recalled: March 23, 2018 Straumann Manufacturing Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot NZ535, Syringe Blaster Lot LP632A, Exp 6/30/2018 Lot PG631, Syringe Blaster Lot MX842B, Exp 2/28/2019 Lot NP739, Syringe Blaster Lot NE101B, Exp 3/31/2019 Lot PY818, Syringe Blaster Lot PT888A, Exp 1/31/2020
  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:
Straumann Manufacturing, Inc.
Reason for Recall:
A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Straumann¿ Emdogain 0.7 ml Multipack. Enamel Matrix Derivative. Article Number 075.116W

Product Codes/Lot Numbers:

Lot NZ535, Syringe Blaster Lot LP632A, Exp 6/30/2018 Lot PG631, Syringe Blaster Lot MX842B, Exp 2/28/2019 Lot NP739, Syringe Blaster Lot NE101B, Exp 3/31/2019 Lot PY818, Syringe Blaster Lot PT888A, Exp 1/31/2020

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1698-2018

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Straumann Manufacturing

Class I - Dangerous

Laser engraved label does not match with the item in the package

Oct 2, 2018 Implants & Prosthetics Nationwide View Details →