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 metal shim between the jaws may detach during the procedure and fall into the surgical field. it has been reported that the detached shim may be undetected and be left behind in the patient.
Model Catalog: 3104PK (Lot serial: All lots prior to 2009-08-14); Model Catalog: 3105PK (Lot serial: All lots prior to 2009-08-14); Model Catalog: 915000PK (Lot serial: all lots prior to 2009-08-14); Model Catalog: 915010PK (Lot serial: all lots prior to 2009-08-14); Model Catalog: 915005PK (Lot serial: all lots prior to 2009-08-14); Model Catalog: 3103PK (Lot serial: All lots prior to 2009-08-14)