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: REM Systems Limited, 69 Elizabeth Knox Place, Glen Innes, AUCKLAND
원인
Potential for the distal tip of the driver to become separated from the driver shaft after successful insertion of the implant.