Device product
CPX4 Breast Tissue Expander 650 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.
Z-2781-2016
Product summary
- Event
- Event 74899
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30 units
- Official record key
device-enforcement:Z-2781-2016
Official wording
Reason: The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.
Code information: Lot 6947019
Distribution pattern: Worldwide Distribution - US Nationwide and the countries of: Germany, UK, and Belgium
Derived failure modes
-
Unknown
The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.