Events

E.T.O.I.L.E sytem extension table (leg holder)(used in total hip arthroplasty) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Amplitude Australia Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2016-RN-01625-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-02-06
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01625-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    Following a customer complaint about the e.To.I.L.E extension table, an analysis of the device showed a failure due to an abnormal wear in the locking system of the external rotation. a failure of the rotation locking mechanism would mean that the rotation of the leg would not be able to be maintained and may have the following consequences:- an increase in the surgery timeline if the incident occurs at the beginning of the surgery.- a risk of injury for the patient if the incident occurs during surgery.There have been no reported patient injuries. as a precautionary measure, amplitude decided to set up a preventive maintenance on all the e.T.O.I.L.E systems on the market.
  • 조치
    Amplitude is arranging for the return of all devices for preventative maintenance. Replacement devices will be provided as necessary.

Device

E.T.O.I.L.E sytem extension table (leg holder)(used in total hip arthroplasty)
  • 모델명 / 제조번호(시리얼번호)
    E.T.O.I.L.E sytem extension table (leg holder)(used in total hip arthroplasty)Reference: 3-0499902Serial Numbers: 1500044, E1210021, E1210022, E1210023ARTG Number: 216762
  • Manufacturer
    Amplitude Australia Pty Ltd

Manufacturer

Amplitude Australia Pty Ltd