Artoura Breast Tissue Expander 700 cc Product Usage: Tissue 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.
Reported: September 21, 2016 Initiated: August 9, 2016 #Z-2780-2016
Product Description
Artoura Breast Tissue Expander 700 cc Product Usage: Tissue 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.
Reason for Recall
The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.
Details
- Recalling Firm
- Mentor Texas, LP.
- Units Affected
- 48 units
- Distribution
- Worldwide Distribution - US Nationwide and the countries of: Germany, UK, and Belgium
- Location
- Irving, TX
Frequently Asked Questions
What product was recalled? ▼
Artoura Breast Tissue Expander 700 cc Product Usage: Tissue 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.. Recalled by Mentor Texas, LP.. Units affected: 48 units.
Why was this product recalled? ▼
The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 21, 2016. Severity: Moderate. Recall number: Z-2780-2016.
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