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 orthopaedics has become aware that there is the potential for the above mentioned product to be oversized by a maximum of .024"(0.6mm). it was determined that an oversized tibial insert trial may sit on the anterior edge of the tibial baseplate if used for secondary trialing in a procedure. if there is an inability to seat the insert trial and impaction is used to seat the trial fracture of the device may occur.