FDAFDA · Food and drugs·Recall number Z-2781-2016
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.
Published September 21, 2016 · Recall initiated: August 9, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Mentor Texas, LP.
- Distributor
- Worldwide Distribution - US Nationwide and the countries of: Germany, UK, and Belgium
- Lot
- Lot 6947019
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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