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.
데이터 추가 비고
원인
Synthes canada is initiating a medical device labelling recall related to the synthes zero p instrument and implants technique guide document #j8566 revision c and previous that references the use of peek-cr as a cervical interbody spacer. peek-cr is not currently indicated for use as cervical interbody spacer. there have been no additional risks to the patient identified that are associated with the use of the peek-cr as a cervical interbody spacer.
Model Catalog: 04.617.119S (Lot serial: ALL LOTS); Model Catalog: 04.617.118S (Lot serial: ALL LOTS); Model Catalog: 04.617.117S (Lot serial: ALL LOTS); Model Catalog: 04.617.110S (Lot serial: ALL LOTS); Model Catalog: 04.617.115S (Lot serial: ALL LOTS); Model Catalog: 04.617.112S (Lot serial: ALL LOTS); Model Catalog: 04.617.111S (Lot serial: ALL LOTS); Model Catalog: 04.617.116S (Lot serial: ALL LOTS); Model Catalog: 04.617.137S (Lot serial: ALL LOTS); Model Catalog: 04.617.131S (Lot serial: ALL LOTS); Model Catalog: 04.617.132S (Lot serial: ALL LOTS); Model Catalog: 04.617.139S (Lot serial: ALL LOTS); Model Catalog: 04.617.138S (Lot serial: ALL LOTS); Model Catalog: 04.617.130S (Lot serial: ALL LOTS); Model Catalog: 04.617.136S (Lot serial: ALL LOTS); Model Catalog: 04.617.135S (Lot serial: ALL LOTS); Model Catalog: 04.617.129S (Lot serial: ALL LOTS); Model Catalog: 04.617.128S (Lot serial: ALL LOTS); Model Catalog: 04.617.127S (Lot serial: ALL LOTS); Model Catalog: 04.617.126S (Lot serial: ALL LOTS); Mod