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.
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The os-a-642100 can develop fatigue cracks in normal use over extended period of time and ultimately separate completely. since there is hardly any visible or audible sign indicating potential breakage they strongly recommend retrieval from the field.