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.
데이터 추가 비고
Sizer, mammary, breast implant volume - Product Code MRD
원인
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.
조치
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 questions related to this notice, please contact your local Mentor Sales Representative, or Mentor Customer Service at 1-800-235-5731.