Mentor Texas, LP. recalls CPX4 Breast Tissue Expander 650 cc : Product Usage: Tissue expanders can be used for breast reconstruction after mastec…

Recall date

August 9, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2781-2016

FDA classification

Class II

Brand / firm

Mentor Texas, LP.

Sold / distributed

Worldwide Distribution - US Nationwide and the countries of: Germany, UK, and Belgium

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.