Recall Z-2591-2014 ยท MRD Mammary Sizer
Mentor Texas, LP.
EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer REF 351-3380SZ 380 cc LOT 6830722. Product Usage: This product is indicated for single use for temporary insertion intraoperatively to evaluate the volume of the breast implant to be implanted.
| Date | Sep 4, 2014 (initiated Jul 2, 2014) |
| Status | Terminated |
| Reason | The device labeling is stamped with 330cc and the device is actually 380cc device. |
| Root cause | Error in labeling |
| Action | Mentor sent an Important Customer Notification letter dated July 17, 2014 to all affected customers and follow-up with a visit by the local sales representative. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately identify all unsused product from lot list provided and maintain a copy of this notice with the affected product. For question contact your local Sales Representative or Mentor Customer Service at 1-800-235-5731. |
| Quantity | 34 units |
| Distribution | U.S Nationwide Distribution in the states of Michigan, Maryland, Texas, New Jersey, Indiana, Nevada, Florida, California, New York, Tennessee, Pennsylvania, and Colorado. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010709 | MENTOR STERILE SALINE MAMMARY VOLUME SIZERS Mentor Corp., Apr 23, 2001 |