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.
Recall
- Recall Number
- Z-2780-2016
- Event Number
- 74899
- FEI Number
- 1000118360
- Product Code
- LCJ
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- August 9, 2016
- Posted
- September 10, 2016
- Terminated
- March 8, 2017
- Address
- 3025 Skyway Cir N, Mentor Texas, LP., Irving, TX, 75038-3524
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.
The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.
Mentor Texas sent an Urgent Field Safety Notice dated August 11, 2016 to customers.via letter and a follow-up with respective Sales Representative visit. The letter identified the affected product, problems and actions to be taken. Customers were informed the firm will credit/replace returned affected products. For questions contact your Sales Representative .
Worldwide Distribution - US Nationwide and the countries of: Germany, UK, and Belgium
48 units