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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Synthes (canada) ltd. is initiating a voluntary labelling recall related to the surgical technique guide "plate insertion instruments. for minimally invasive plate ostemynthesis (mipo)." this action has been initiated as a result of review for the previous recall of the soft tissue retractor small extendible (325.010) due to locking nut (clamping sleeve) malfunction. the revised surgical technique guides contains a precaution on page 3 stating "do not overtighten the clamping sleeve as this could lead to breakage". this labelling recall requires that customers review the new technique guides provided in this mailing and replace previous revisions with the revised copies.