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FDAAugust 9, 2016device

MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast reconstruction following mastectomy and are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months.

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

The hazard

Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc

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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MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast reconstruction following mastectomy and are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months. — Recall Details · AllClear