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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This recall is being initiated because synthes identified the potential for non-conforming helical blades to have been distributed to the field.
Model Catalog: 456.307S (Lot serial: 5615864 through 7423581); Model Catalog: 456.307 (Lot serial: 5615864 through 7423581); Model Catalog: 456.306S (Lot serial: 5615864 through 7423581); Model Catalog: 456.306 (Lot serial: 5615864 through 7423581); Model Catalog: 456.305S (Lot serial: 5615864 through 7423581); Model Catalog: 456.305 (Lot serial: 5615864 through 7423581); Model Catalog: 456.304S (Lot serial: 5615864 through 7423581); Model Catalog: 456.304 (Lot serial: 5615864 through 7423581); Model Catalog: 456.303S (Lot serial: 5615864 through 7423581); Model Catalog: 456.303 (Lot serial: 5615864 through 7423581); Model Catalog: 456.302S (Lot serial: 5615864 through 7423581); Model Catalog: 456.302 (Lot serial: 5615864 through 7423581); Model Catalog: 456.301S (Lot serial: 5615864 through 7423581); Model Catalog: 456.301 (Lot serial: 5615864 through 7423581); Model Catalog: 456.300S (Lot serial: 5615864 through 7423581); Model Catalog: 456.300 (Lot serial: 5615864 through 7423581); Model Catalog: 456.308