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.
Microscopic cracks potential for pre-mature revisions in patients implanted with the system.
조치
ConforMIS contacted accounts and presented the surgeon with the customer communication letter dated April 23, 2009, customized for the surgeon by serial number and patient identification. Product not yet implanted will be recovered. A patient evaluation and monitoring protocol will be recommended for potentially affected product already implanted.
Contact ConforMIS for further questions at 1-781-345-9164.
Worldwide Distribution - US including states of CA, LA, MI and TX and Germany.
제품 설명
ConforMIS iUni ( Unicondylar Knee System iUni Right Lateral Implant Kit Product Code: M57220600040. || For cemented use only. System consists of femoral and tibial components. The femoral component is CoCrMo personalized on its sub-chondral and articular surfaces to match patient's anatomy. For use in one compartment of the osteoarthritic knee to replace the damaged area of the articular surface in patients with evidence of inadequate healthy bone for support of the implanted component.