Recall Z-2326-2016 ยท FTR Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
Mentor Texas, LP.
Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction.
| Date | Jul 1, 2016 |
| Status | Terminated |
| Reason | The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates. |
| Root cause | Labeling mix-ups |
| Action | The affected consignees were notified via customer letter on 7/1/16, and a follow-up with respective sales representative via visit. |
| Quantity | 35 units |
| Distribution | Distributed in the states of NY, WI, CA, TX, CO, NC, NJ, OH, TN, RI, and IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.