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
Synthes (canada) ltd. is initiating a medical device labelling recall related to the synthes synfix-lr system technique guide specifically regarding use of the synfix implant holder. the surgical technique presented in the guide has been revised and emphasizes the importance of ensuring that the synfix-lr implant holder is not cross threaded when attached to the synfix-lr implant. the revision also describes the use of holding forceps.