Reported Sep 14, 2016 · Terminated
MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue…
Mentor Texas, LP.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mentor Texas, LP. · 3025 Skyway Cir N · Irving, TX · 75038-3524
Is this the product you have?
- MENTOR 2"
- Tall Height TE With Sutures 350cc PN354-9312 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
- Lot codes and dates
- Lot 6981537
- Amount recalled
- 65 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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