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Mentor Texas, LP. recalls MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expa
Recalled September 14, 2016 · FDA recall Z-2747-2016 · Mentor Texas
Hazard
Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc · FDA Class II
Units
65 units
Sold at
Worldwide Distribution: US (nationwide) and countries of: South Korea, Argentina, Mexico, Canada, Australia and New Zealand.
Description
Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc
Product
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.
Manufacturer(s)
Mentor Texas, LP.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →