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FDAAugust 9, 2016device

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 ar...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

mentor texas lpmentormentor texas

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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 ar... — Recall Details · AllClear