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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Synthes (canada) ltd. is initiating a medical device labelling recall related to the synthes t-pal spacer system specifically regarding the use of the t-pal spacer with allograft material. this action has been initiated following a regulatory review of all labelling and promotional materials associated with the t-pal spacer system which is currently only indicated for use with autograft. there have been no additional risks to the patient identified associated with the use of the t-pal spacer system with allograft material.
Model Catalog: 08.812.217 (Lot serial: ALL LOTS); Model Catalog: 08.812.007 (Lot serial: ALL LOTS); Model Catalog: 08.812.215 (Lot serial: ALL LOTS); Model Catalog: 08.812.214 (Lot serial: ALL LOTS); Model Catalog: 08.812.213 (Lot serial: ALL LOTS); Model Catalog: 08.812.212 (Lot serial: ALL LOTS); Model Catalog: 08.812.211 (Lot serial: ALL LOTS); Model Catalog: 08.812.210 (Lot serial: ALL LOTS); Model Catalog: 08.812.209 (Lot serial: ALL LOTS); Model Catalog: 08.812.208 (Lot serial: ALL LOTS); Model Catalog: 08.812.207 (Lot serial: ALL LOTS); Model Catalog: 08.812.017 (Lot serial: ALL LOTS); Model Catalog: 08.812.016 (Lot serial: ALL LOTS); Model Catalog: 08.812.015 (Lot serial: ALL LOTS); Model Catalog: 08.812.014 (Lot serial: ALL LOTS); Model Catalog: 08.812.013 (Lot serial: ALL LOTS); Model Catalog: 08.812.012 (Lot serial: ALL LOTS); Model Catalog: 08.812.011 (Lot serial: ALL LOTS); Model Catalog: 08.812.010 (Lot serial: ALL LOTS); Model Catalog: 08.812.009 (Lot serial: ALL LOTS); Model Catalog: 08.812.0