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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Greatbatch had originally identified through internal sterility assurance level validation testing that a sterility assurance level of 10-6 is not achieved on the standard offset cup impactor when it is subjected to the steam sterilization cycles and associated dry times that are specified in the current instructions for use (ifu) provided with the device. the standard offset cup impactor is provided non-sterile and must be sterilized prior to use in a surgery. stryker orthopedics then took additional risk mitigation steps to include the removal of the blue plastic handle. all modified units (t6318) are now being removed from the field.