EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer REF 351-3380S
FDA device recall Z-2591-2014 · posted 2014-09-04 · Terminated
Recall details
- Recalling firm
- Mentor Texas, LP.
- Reason for recall
- The device labeling is stamped with 330cc and the device is actually 380cc device.
- Action taken
- 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.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- MRD
- Quantity affected
- 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.
- Date initiated
- 2014-07-02
- Date posted
- 2014-09-04
- Date terminated
- 2015-04-06
- Location
- Irving, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MENTOR STERILE SALINE MAMMARY VOLUME SIZERS (K010709) | Mentor Corp. | 2001-04-23 |