Events

Guide Wire Ø 3.2 mm, length 400 mm (used for the implantation of intramedullary nails) 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-00371-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-03-27
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00371-1
  • 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 wrong material (stainless steel) is indicated on the product label. the product is made of cobalt chrome. there is a potential harm associated with the mislabelled product for adverse tissue reaction especially if the guidewire breaks during surgery and a fragment is retained.
  • 조치
    Synthes is notifying their customers of the incorrect information on the product labels and is providing additional safety advice to mitigate the risk of cobalt sensitivity reactions.

Device

Guide Wire Ø 3.2 mm, length 400 mm (used for the implantation of intramedullary nails)
  • 모델명 / 제조번호(시리얼번호)
    Guide Wire Ø 3.2 mm, length 400 mm (used for the implantation of intramedullary nails)Part number: 357.399Lot Numbers: All lot numbers prior to 7527384 ARTG Number: 203637
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd