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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It was detected in qc control that the hole used to thread the solis trial onto the implant holder was manufactured on the left side of the instrument instead of the right as indicated on the engineering print. this leads to the trial being placed upside down on the handle. the implant handle has markings indicating the cranial and caudal sides on the top and bottom respectively. the nonconforming trials result in the cranial side of the trial being inserted facing caudal.