Events

Guide Wire diameter 3.2mm, length 400mm (Fixation nail guidewire) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Synthes 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-2014-RN-00611-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-06-06
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00611-1
  • 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
    The packaging for the selected part and lot numbers of the guide wire ø 3.2 mm, length 400 mm were mislabelled with an incorrect material. the label incorrectly declares 'molybdenum' instead of wolfram and nickel as alloyed elements. the correct label should indicate “cocrwni alloy”. during the normal course of the surgery, the risk of adverse tissue reaction is decreased as the guide wire is not retained in the body after the procedure is completed. in the case of a broken guide wire, a fragment may be retained after surgery. in this case, a patient with sensitivity to nickel could develop a moderate adverse tissue reaction.
  • 조치
    Customers are advised to immediately isolate the affected stock for returning to Synthes Australia.

Device

Guide Wire diameter 3.2mm, length 400mm (Fixation nail guidewire)
  • 모델명 / 제조번호(시리얼번호)
    Guide Wire diameter 3.2mm, length 400mm (Fixation nail guidewire)Part Number: 357.399Lot Numbers: 7560756, 7584396, 7594896, 7560829, 7562800, 7589236, 7594058, 7583667, 7589696 and 7594057 ARTG Number: 203637
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd