Events

Inserter f/TEN 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes 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-2015-RN-00185-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-03-11
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00185-1
  • 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 affected lots of the inserter for titanium elastic nails (ten) may have the potential for breakage during use. it is important to note that the removal of the ten inserter would prevent the performance of emergency surgery, thus synthes gmbh is not requiring an immediate return of affected product(s).
  • 조치
    JJM is providing work around instructions to prevent the breaking of the cross/transversal bar and jamming of the chuck. The manufacturer, Synthes GmbH, is in the process of developing the replacement & recovery plan for indicated devices and will contact their customers as replacements become available. This action has been closed-out on 06/06/2016.

Device

Inserter f/TEN

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes