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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Stryker received a product experience report (per) that a swivel block was improperly oriented on a triathlon tibial alignment handle. the locator holes on the alignment guide handle on which the swivel block is mounted are not in alignment as per print. the tibial alignment handle was not machined properly on the 5 axis machine because the tibial alignment handle was not fixtured properly on the machine by the operator. the fixturing procedure involved manually locating every part in a collet aligning datum c using a square and locking the part in position for machining of the slot and cross hole. additionally the particular feature was not inspected during in-process and/or final inspection at the vendor. hence the non-conformance was not detected.