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 has verified the wrap for single use for nail sterilization but does not have sufficient testing for the device to be considered a multi-use item. the decision to recall was made to address the potential for multiple use of the wrap.