Events

Triathlon Modular Handle(a reusable surgical instrument used in total and partial knee replacements) 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-00910-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-07-08
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00910-1
  • 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 complaints from customers about the device dissociating or breaking during use. an analysis indicated that the press fit specifications between the dowel pin and the mating hole in the shaft were not being achieved by the supplier, potentially resulting in disassociation from the instrument. there is a risk that the handle components, including a dowel pin and a locking pin, may potentially disassociate and fall into the wound intraoperatively, necessitating retrieval. there have been no injuries reported as a result of this issue.
  • 조치
    Stryker is advising users to inspect inventory and remove the affected devices from the procedure trays. The trays can continue to be used once the affected items have been removed. The affected devices can be returned to Stryker.

Device

Triathlon Modular Handle(a reusable surgical instrument used in total and partial knee replacements)
  • 모델명 / 제조번호(시리얼번호)
    Triathlon Modular Handle(a reusable surgical instrument used in total and partial knee replacements)Item Number: 6541-4-808All Lot Numbers ARTG Number: 140892
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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