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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Recent testing shows that the transfer piece which accompanies the palatal implant may get stuck on the implant during placement and may only be removed by applying mechanical forces.
Model Catalog: 042.336S (Lot serial: lot 1001 catalog # 042.336S); Model Catalog: 042.335S (Lot serial: lot 1001 catalog # 042.336S); Model Catalog: 042.336S (Lot serial: lot 1001 catalog # 042.335S); Model Catalog: 042.335S (Lot serial: lot 1001 catalog # 042.335S); Model Catalog: 042.336S (Lot serial: lot E3289 catalog # 042.335S); Model Catalog: 042.335S (Lot serial: lot E3289 catalog # 042.335S); Model Catalog: 042.336S (Lot serial: lot F3776 catalog # 042.335S); Model Catalog: 042.335S (Lot serial: lot F3776 catalog # 042.335S); Model Catalog: 042.335S (Lot serial: lot F0597 catalog # 042.335S); Model Catalog: 042.335S (Lot serial: lot E5455 catalog # 042.335S); Model Catalog: 042.336S (Lot serial: lot E5455 catalog # 042.335S); Model Catalog: 042.335S (Lot serial: lot F4662 catalog # 042.335S); Model Catalog: 042.336S (Lot serial: lot F4662 catalog # 042.335S); Model Catalog: 042.335S (Lot serial: lot C9930 catalog # 042.335S); Model Catalog: 042.336S (Lot serial: lot C9930 catalog # 042.335S); Model C