Mentor Texas, LP. recalls MENTOR 2" Tall Height TE With Sutures 450cc PN: 354-9313 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expand…

Recall date

August 9, 2016

Source

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

Recall number

Z-2748-2016

FDA classification

Class II

Brand / firm

Mentor Texas, LP.

Sold / distributed

Worldwide Distribution: US (nationwide) and countries of: South Korea, Argentina, Mexico, Canada, Australia and New Zealand.

Why it was recalled

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

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

What was recalled

MENTOR 2" Tall Height TE With Sutures 450cc PN: 354-9313 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.