U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Mentor sent an Recall Notification letter dated March 27, 2017 was sent to consignees (hospitals/doctors) .
Actions Requested
If you have already implanted a device from this lot, there is no risk to patient health and you do not need to take any action.
Immediately identify all unused units and return them to Mentor per the normal return process.Forward this notice to anyone in your facility that needs to be informed.
If you have sent these units to another facility, forward this notice to that facility.
Maintain awareness of this notice until all units from lot number 7377332 in your inventory have been returned.
We apologize for any inconvenience this may cause. Mentor stands confidently behind the safety and quality of the products we supply, and we appreciate your cooperation in this matter.
Please know the U.S. Food and Drug Administration (FDA) has been notified of this voluntary field action. If you have any questions related to this notice, please contact your local Mentor Sales Representative or Mentor Customer Service at 1-800-235-5731. For further questions please call (972) 252-6060.
Thank you for your attention and cooperation.