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
On september 17th 2015 silimed had its ce mark suspended due to the discovery of microscopic particles on the surface of some of its implants tested by tuv in a recent audit. silimed has been given a limit period of 90 days to produce technical reports and treat the non-conformities reported.
Model Catalog: 3232-050 (Lot serial: 8471004); Model Catalog: 3232-045 (Lot serial: 8471004); Model Catalog: 3232-040 (Lot serial: 8471004); Model Catalog: 3232-030 (Lot serial: 8471004); Model Catalog: 3232-050 (Lot serial: 8474209); Model Catalog: 3232-045 (Lot serial: 8474209); Model Catalog: 3232-040 (Lot serial: 8474209); Model Catalog: 3232-030 (Lot serial: 8474209); Model Catalog: 3232-050 (Lot serial: 8474210); Model Catalog: 3232-045 (Lot serial: 8474210); Model Catalog: 3232-040 (Lot serial: 8474210); Model Catalog: 3232-030 (Lot serial: 8474210); Model Catalog: 3232-050 (Lot serial: 8474211); Model Catalog: 3232-045 (Lot serial: 8474211); Model Catalog: 3232-040 (Lot serial: 8474211); Model Catalog: 3232-030 (Lot serial: 8474211); Model Catalog: 3232-050 (Lot serial: ALL LOTS); Model Catalog: 3232-045 (Lot serial: ALL LOTS); Model Catalog: 3232-040 (Lot serial: ALL LOTS); Model Catalog: 3232-030 (Lot serial: ALL LOTS); Model Catalog: 3521-140 (Lot serial: 4442190); Model Catalog: 3521-120 (Lot ser