Recall Z-2781-2016 ยท LCJ Tissue Expander And Accessories
Mentor Texas, LP.
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.
| Date | Sep 10, 2016 (initiated Aug 9, 2016) |
| Status | Terminated |
| Reason | The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box. |
| Root cause | Employee error |
| Action | 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 . |
| Quantity | 30 units |
| Distribution | Worldwide Distribution - US Nationwide and the countries of: Germany, UK, and Belgium |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130813 | MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS Mentor Corp., Apr 11, 2013 |