Recall Z-2781-2016
Mentor Texas, LP. · initiated August 9, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot 6947019
Reason for recall
The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.
FDA-determined cause: Employee error
Action taken
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 .
Details
- Recall number
- Z-2781-2016
- Initiated
- August 9, 2016
- Posted by FDA
- September 10, 2016
- Terminated
- March 8, 2017
- Product code
- LCJ – Tissue Expander And Accessories
- Quantity
- 30 units
- Distribution
- Worldwide Distribution - US Nationwide and the countries of: Germany, UK, and Belgium
- Recalling firm
- Mentor Texas, LP., Irving, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2780-2016 Class II | Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders can be used for…The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box. | 08/09/2016Terminated |