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
Through an investigation into complaints about the delamination (polyethylene layer separating from sms layer) stryker instruments discovered that rolls of raw material from stryker's supplier had burst test values below (less than 3psi) the specifications set by stryker (minimum of 3psi). as such raw materials received from the supplier were not within specification leading to a potential for delamination (separation of material layers) to occur.