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 medical device labelling recall for synthes reamer/irrigator /aspirator (ria) system technique guide (j4352). precautionary statements are being added to the "reamer /irrigator/ aspirator (ria) surgical technique guide". it was reported that the ria drive shaft tube assembly and reamer head have the potential to break when incorrectly assembled or used improperly as follows: 1. failure to fully engage the reamer to shaft at assembly prior to surgery. incorrect assembly creates a reduced reamer/shaft contact surface area in which excess rotational forces could cause breakage 2. use of ria drive shafts after the flats have become worn and rounded 3. use of any excess force beyond design limit 4. use of with an incompatible power tool.
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