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Mentor Texas, LP. recalls CPX4 Breast Tissue Expander 650 cc : Product Usage: Tissue expanders can be used for breast reconstruction after mast
Recalled September 21, 2016 · FDA recall Z-2781-2016 · Mentor Texas
Hazard
The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box. · FDA Class II
Units
30 units
Sold at
Worldwide Distribution - US Nationwide and the countries of: Germany, UK, and Belgium
Description
The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.
Product
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.
Manufacturer(s)
Mentor Texas, LP.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →