🔍 RecallPedia

Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model): N1520 - Product Usage: Neomem is a bioresorbable, implantable collagen material that is intended for use in dental surgery procedures as a material for placement in the area of dental implant, bone defect or ridge reconstruction to aid in wound healing post dental surgery. Neomem¿ is also intended for use in patients with moderate to severe periodontal disease as a material for placement in periodontal defects to aid in wound healing of periodontal tissue.

Class I - Dangerous
🏥 Medical Devices Recalled: March 19, 2019 Collagen Matrix Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot Number: OCF191255 UDI (01)00813954020884(17)211130(10)OCF191255
  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:
Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model): N1520 - Product Usage: Neomem is a bioresorbable, implantable collagen material that is intended for use in dental surgery procedures as a material for placement in the area of dental implant, bone defect or ridge reconstruction to aid in wound healing post dental surgery. Neomem¿ is also intended for use in patients with moderate to severe periodontal disease as a material for placement in periodontal defects to aid in wound healing of periodontal tissue.

Product Codes/Lot Numbers:

Lot Number: OCF191255 UDI (01)00813954020884(17)211130(10)OCF191255

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1389-2019

Related Recalls