Recall Z-0964-2015 ยท MRD Mammary Sizer
Mentor Texas, LP.
MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer.
| Date | Jan 13, 2015 (initiated Dec 11, 2014) |
| Status | Terminated |
| Reason | The IFU provided in the affected units of the MENTOR MemoryGel Resterilizable Sizer is incorrect. Those units include the IFU for the MENTOR MemoryShape Resterilizable Sizer. |
| Root cause | Employee error |
| Action | Mentor sent an Important Labeling Correction letter dated December 19, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm plans to follow-up with sales representative visits. The recall letter notifies the customer of the issue, but does not instruct them to return the product. Should the customer chose to return the product, all returned product will be tagged to denote no further distribution. The recalled units under firm control have been placed on hold in the inventory system. If you have any ques |
| Quantity | 45 units |
| Distribution | US Distribution to the states of : MA, WV, NY, FL, ME, NC, TX, IL, KS, TN, NJ, PA, CA, OR, WI, GA, and WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062421 | MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER Mentor Corporation, Oct 10, 2006 |