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
This recall has been initiated due to a drill bit mix-up.Ddk2-2.4-30x disposable drill kits and ddk2-2.8-30x disposable drill kits were found to be packaged at the same time causing devices to be labeled incorrectly.