FDA-Device2016-09-21Class II
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.
Mentor Texas, LP.
Hazard
The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.
Sold states
Worldwide Distribution - US Nationwide and the countries of: Germany, UK, and Belgium
Affected count
30 units
Manufactured in
3025 Skyway Cir N, N/A, Irving, TX, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2781-2016Don't want to check this manually?
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