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 internally identified that the a select batch of the variax bone screws had been manufactured with the incorrect raw material. screws should be grade 5 titanium [t005] but were made with grade 4 titanium [t014]. no hazards were identified. both materials are used for stryker osteosynthesis implant screws and both materials have very good biocompatible characteristics. the substitution for t014 / t005 for the screws does not represent a significant incremental medical risk to the patient.