🔍 RecallPedia

CPX4 Breast Tissue Expander 650 cc : Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or sub muscular implantation and are not intended for use beyond six months.

Class I - Dangerous
🏥 Medical Devices Recalled: August 9, 2016 Mentor Texas Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot 6947019
  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:
Mentor Texas, LP.
Reason for Recall:
The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

CPX4 Breast Tissue Expander 650 cc : Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or sub muscular implantation and are not intended for use beyond six months.

Product Codes/Lot Numbers:

Lot 6947019

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2781-2016

Related Recalls

MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elastomer, made of polydimethylsiloxane. Surgeons inflate the silicone elastomer shell to the desired size with sterile isotonic saline before implantation. The implants are available with SILTEX Textured or smooth surface shells. Each implant is supplied sterile with a disposable fill tube and reflux valve.

Mentor Texas

Class I - Dangerous

Due to a manufacturing issue, Implant may have a potentially weakened area on the base patch portion of the implant which may cause leakage/deflation of the affected device.

Sep 30, 2021 Implants & Prosthetics Nationwide View Details →

Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or sub muscular implantation and are not intended for use beyond six months.

Mentor Texas

Class I - Dangerous

The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.

Aug 9, 2016 Implants & Prosthetics Nationwide View Details →