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 current directions for use for the mca cutting burrs and mca micro curved attachment do not provide clear details regarding the intended use specifically for the mca burrs. the use of the device in dense bone removal may result in cutter fracture.
Model Catalog: MCA7-15SB (Lot serial: ALL LOTS); Model Catalog: MCA5-2SB (Lot serial: ALL LOTS); Model Catalog: MCA5-1SB (Lot serial: ALL LOTS); Model Catalog: MCA_AO (Lot serial: ALL LOTS); Model Catalog: MCA (Lot serial: ALL LOTS); Model Catalog: MCA7-1SB (Lot serial: ALL LOTS); Model Catalog: MCA7-2SB (Lot serial: ALL LOTS); Model Catalog: MCA5-15SB (Lot serial: ALL LOTS); Model Catalog: MCA5-08SD (Lot serial: ALL LOTS); Model Catalog: MCA5-15SD (Lot serial: ALL LOTS); Model Catalog: MCA5-1SD (Lot serial: ALL LOTS); Model Catalog: MCA5-2SD (Lot serial: ALL LOTS); Model Catalog: MCA7-05SD (Lot serial: ALL LOTS); Model Catalog: MCA7-06SD (Lot serial: ALL LOTS); Model Catalog: MCA7-07SD (Lot serial: ALL LOTS); Model Catalog: MCA7-08SD (Lot serial: ALL LOTS); Model Catalog: MCA7-15SD (Lot serial: ALL LOTS); Model Catalog: MCA7-1SD (Lot serial: ALL LOTS); Model Catalog: MCA5-05SD (Lot serial: ALL LOTS); Model Catalog: MCA5-06SD (Lot serial: ALL LOTS); Model Catalog: MCA5-07SD (Lot serial: ALL LOTS); Model Cata