🔍 RecallPedia

Multi-Unit Abutment Angled, 17¿, 4mm Cuff 4.1/4.5mm TiLobe¿ Implants, Catalog Number 45324K pRODUCT Usage: Use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations and terminal or intermediate abutment support for fixed bridgework.

Class I - Dangerous
🏥 Medical Devices Recalled: June 20, 2017 Keystone Dental Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    REF - 45324K Lot Number - 33006 Expiry Date - March 31, 2022
  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:
Keystone Dental Inc
Reason for Recall:
Abutments are unable to accept the final abutment screw
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Multi-Unit Abutment Angled, 17¿, 4mm Cuff 4.1/4.5mm TiLobe¿ Implants, Catalog Number 45324K pRODUCT Usage: Use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations and terminal or intermediate abutment support for fixed bridgework.

Product Codes/Lot Numbers:

REF - 45324K Lot Number - 33006 Expiry Date - March 31, 2022

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0608-2018

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