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 is placing the otismed shape match cutting guides on hold to investigate product experience reports. the product will be on hold until the investigation is complete. at this time a product field action will be initiated to inform all surgeons registered on the otismed.Net website and all imaging centers to refrain from prescribing or performing mri or ct arthrogram for use with otismed shape match cutting guides while the investigation continues.