Recall Z-2591-2014
Mentor Texas, LP. · initiated July 2, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Part Number (PN) 351-3380SZ Lot Number 6830722
Reason for recall
The device labeling is stamped with 330cc and the device is actually 380cc device.
FDA-determined cause: Error in labeling
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.
Details
- Recall number
- Z-2591-2014
- Initiated
- July 2, 2014
- Posted by FDA
- September 4, 2014
- Terminated
- April 6, 2015
- Product code
- MRD – Mammary Sizer
- 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.
- Recalling firm
- Mentor Texas, LP., Irving, TX