Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
데이터 추가 비고
Recalling Organisation: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
원인
The manufacturer is updating the instructions for use to remove morcellation from the intended use, warnings and the instructions, and to add a contraindication.