🔍 RecallPedia

Max Implant System - Bone Tap for use with 7.0mm diameter Max Implant, Catalog Number D-TAP-MAX7-7 Dental implants are intended for use as anchors of fixed or semi-fixed dental crowns, bridges, and overdentures in patients with partial or full edentulism of the upper or lower jaw.

Class I - Dangerous
🏥 Medical Devices Recalled: June 16, 2017 Keystone Dental Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    Catalog Number D-TAP-MAX7-7, Lot 31444
  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:
An 8mm diameter bone tap was laser marked as 7mm diameter and was packed with a 7mm label.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Max Implant System - Bone Tap for use with 7.0mm diameter Max Implant, Catalog Number D-TAP-MAX7-7 Dental implants are intended for use as anchors of fixed or semi-fixed dental crowns, bridges, and overdentures in patients with partial or full edentulism of the upper or lower jaw.

Product Codes/Lot Numbers:

Catalog Number D-TAP-MAX7-7, Lot 31444

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0718-2018

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