🔍 RecallPedia

Neodent¿ GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are intermediary prosthetic components to be installed onto GM implants to support the final prosthesis. They are provided in a rotational shape for the coupling with the prosthesis and in different gingival heights to match the variations in mucosal thickness. The GM Exact Mini Conical abutment is provided angled. They are indicated for screw-retained multiple-unit prostheses onto implants Article Number: 115244

Class I - Dangerous
🏥 Medical Devices Recalled: October 2, 2018 Straumann Manufacturing Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot Number: 800327510 UDI: (01)07899878026488(11)171110(17)221110(10)800327510
  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:
Laser engraved label does not match with the item in the package
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Neodent¿ GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are intermediary prosthetic components to be installed onto GM implants to support the final prosthesis. They are provided in a rotational shape for the coupling with the prosthesis and in different gingival heights to match the variations in mucosal thickness. The GM Exact Mini Conical abutment is provided angled. They are indicated for screw-retained multiple-unit prostheses onto implants Article Number: 115244

Product Codes/Lot Numbers:

Lot Number: 800327510 UDI: (01)07899878026488(11)171110(17)221110(10)800327510

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0455-2019

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