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.
Mislabeled: incorrect serial number on the f4 a/p cut guide ijig.
조치
ConforMIS notified the sales representative on 10/18/16 after it became aware of the device mix-up. The sales representative was requested to return any remaining components from iTotal CR kit S/N: 0381042.
ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile || Catalog Number: TCR-111-1111. || Intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use || of a prosthetic device.