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.
Iview report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm).
조치
ConForMIS intiated the recall by telephone on October 31, 2016, to the Sales Rep to request return of the kit.
For questions regarding this recall call 781-345-9001.
ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT || Catalog Number:TPS-111-1111 || The iTotal¿ PS Knee Replacement System is 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 that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis