🔍 RecallPedia

Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.

Class I - Dangerous
🏥 Medical Devices Recalled: July 21, 2017 Implant Direct Sybron Manufacturing Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    Product Code 9048-13H, Lot No. 81080
  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:
Implant Direct Sybron Manufacturing, LLC
Reason for Recall:
The Swish Duo-Grip Healing Collar part number 9048-13H (4.8mm) package contained a 9037-13H (3.7 mm) component.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.

Product Codes/Lot Numbers:

Product Code 9048-13H, Lot No. 81080

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0007-2018

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