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 received a complaint regarding a standard lag screw omega 110mm length. it was reported that the lag screw was not completely cannulated and the guide wire could not go through the cannula of the screw. no harm reported. the investigation revealed that the obstruction is related to a metal burr in the cannula of the screw which was not removed during manufacturing. the non-conformance is limited to 2 batches.