FDA-Device2016-09-14Class II
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.
Mentor Texas, LP.
Hazard
Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc
Sold states
Worldwide Distribution: US (nationwide) and countries of: South Korea, Argentina, Mexico, Canada, Australia and New Zealand.
Affected count
70 units
Manufactured in
3025 Skyway Cir N, Irving, TX, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2748-2016Don't want to check this manually?
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