🔍 RecallPedia

Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in preparation for dental implant placement

Class I - Dangerous
🏥 Medical Devices Recalled: April 16, 2015 BioHorizons Implant Systems Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot Number 1501968
  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:
BioHorizons Implant Systems Inc
Reason for Recall:
BioHorizons Tapered HD Upgrade set was packaged with an incorrect drill component manufactured of stainless steel in place of the correct component manufactured from titanium.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in preparation for dental implant placement

Product Codes/Lot Numbers:

Lot Number 1501968

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1605-2015

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