Events

Exeter Non V40 Rasp with plastic handle (reusable instrument used for the implantation Exeter femoral hip system) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Stryker 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-00934-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-07-14
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00934-1
  • 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
    Stryker has received product complaints stating that a rivet or rivets came off an exeter non v40 rasp handle. these complaints are associated with the exeter rasp handles with either the green or black plastic lever, manufactured between january 1995 and october 2005. the current exeter v40 rasp handles with a metallic lever are not within the scope of this recall. in the event that a rivet comes off the exeter non v40 rasp handle during surgery there are several hazards that would increase surgical time. these include locating the fragment, retrieving a sterilised replacement rasp handle and potentially an intra-operative x-ray if required. the exeter non v40 rasp handle may continue to function without the rivet.
  • 조치
    Stryker is advising users to inspect inventory and quarantine and remaining units of the affected product for return. This action has been closed out on 15 June 2017.

Device

Exeter Non V40 Rasp with plastic handle (reusable instrument used for the implantation Exeter fem...
  • 모델명 / 제조번호(시리얼번호)
    Exeter Non V40 Rasp with plastic handle (reusable instrument used for the implantation Exeter femoral hip system)Product Code: 0930-9-003All lots manufactured between January 1995 and October 2005ARTG Number: 140892
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • 제조사 모회사 (2017)
    Stryker
  • Source
    DHTGA