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 has become aware that the third party supplier for material used to manufacture the cancellous bone screws and gap plate screw did not comply with metallurgical requirements outlined in the astm standards for titanium surgical implants. as such areas of modified material properties may result which may affect the intended use of the product. although testing demonstrated the affected lots to have shear strength equivalent to screws manufactured from non-affected material the potential for variablity of the material used in manufacturing the affected lots could compromise the strength.