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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The stryker rf multigen generator is part of the interventional spine (ivs) portfolio. the stryker rf multigen in combination with the stryker rf electrodes cables and cannulae are intended for coagulation of soft tissues in orthopedic spinal and neurosurgical applications. during testing it was found that incorrect information regarding sterilization for the multigen cables is listed in the care instructions and/or ifu packaged with the stryker rf multigen generator. the care instructions explain information regarding the cleaning and sterilization of the rf multigen system including the cables. previously distributed care instructions/instructions for use incorrectly contained instructions supporting the sterilization of the multigen cables.