Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 Recalled by Mentor Texas, LP. Due to Tissue expander product mix found: CPX4 350cc was...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Mentor Texas, LP. directly.
Affected Products
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.
Quantity: 65 units
Why Was This Recalled?
Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Mentor Texas, LP.
Mentor Texas, LP. has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report