🔍 RecallPedia

Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant component, used temporarily during impressions for the prosthetic procedure.

Class I - Dangerous
🏥 Medical Devices Recalled: May 29, 2018 Implant Direct Sybron Manufacturing Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    Part number 8735-05, Lot number 90212
  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:
Cap may be mislabeled with incorrect part number, although the correct part number is on the main vial label.
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 Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant component, used temporarily during impressions for the prosthetic procedure.

Product Codes/Lot Numbers:

Part number 8735-05, Lot number 90212

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0089-2019

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Class I - Dangerous

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