🔍 RecallPedia

GIBSON Healthcare Membrane 6-9, 15mm x 20mm, Reference Number 5303-226 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.

Class I - Dangerous
🏥 Medical Devices Recalled: November 5, 2019 Collagen Matrix Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI: (01)00366975013248(17)200630; Lot Number PDMU18F1, PDMU19A1
  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:
Collagen Matrix Inc
Reason for Recall:
The products may have been packaged with an incorrect Instructions for Use.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

GIBSON Healthcare Membrane 6-9, 15mm x 20mm, Reference Number 5303-226 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.

Product Codes/Lot Numbers:

UDI: (01)00366975013248(17)200630; Lot Number PDMU18F1, PDMU19A1

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0907-2020

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