🔍 RecallPedia

GM Helix Acqua Implant 3.5x10, Article No. 140.944

Class I - Dangerous
🏥 Medical Devices Recalled: October 11, 2021 Jjgc Industria E Comercio De Materials Dentarios Sa Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI 7899878024897 Lots GNW15 and GRE82
  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:
Jjgc Industria E Comercio De Materials Dentarios Sa
Reason for Recall:
3.5x11.5mm implants were mislabeled as 3.5x10mm implants. In borderline cases where the bone quality is low and the bone ridge has a maximum indication for the implant height (10mm), if the incorrect implant is installed, it could result in damage to the nerve or adjacent bone structures/cavities.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

GM Helix Acqua Implant 3.5x10, Article No. 140.944

Product Codes/Lot Numbers:

UDI 7899878024897 Lots GNW15 and GRE82

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0203-2022

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