Reported Sep 21, 2016 · Terminated
Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders can be used for breast reconstruction after…
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?
- Artoura Breast
- Tissue Expander 700 cc Product UsageTissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or sub muscular implantation and are not intended for use beyond six months
- Lot codes and dates
- Lot 6944785
- Amount recalled
- 48 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
The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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