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
Stryker has become aware that one of the two posts on the anterior skim cutting guide could disassociate from the main body of the part which has been determined to be caused by a fractured weld. welds can fracture in the high stress zone when the post is under bending condition. this bending load could occur during normal surgery or by typical cleaning/handling processes.