Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
데이터 추가 비고
원인
Within the framework of our market surveillance we have been made aware of one complaint in which a break of a weld of the support arm occurred. due to the break the complete support arm could fall down. the problem was caused by inaccurate execution of the weld at a supplier. it cannot be excluded that further support arms of the femur hook devices are equipped with a faulty weld which finally could lead to the failure described above.