Recall Z-2748-2016 ยท LCJ Tissue Expander And Accessories
Mentor Texas, LP.
MENTOR 2" Tall Height TE With Sutures 450cc PN: 354-9313 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast reconstruction following mastectomy and are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months.
| Date | Sep 7, 2016 (initiated Aug 9, 2016) |
| Status | Terminated |
| Reason | Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc |
| Root cause | Employee error |
| Action | The firm, Mentor, sent an "MEDICAL DEVICE REMOVAL" letter dated 8/11/2016 to affected consignees. The letter will be followed up with a respective sales representative visit. The letter described the product, problem and actions to be taken. The consignees were instructed to immediately identify all unused units and return them per the normal return process; forward the letter to anyone your facility that needs to be informed; if you have sent these units to another facility, forward the letter to that facility; and maintain awareness of the letter until all units in your inventory have been |
| Quantity | 70 units |
| Distribution | Worldwide Distribution: US (nationwide) and countries of: South Korea, Argentina, Mexico, Canada, Australia and New Zealand. |
| 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 |