Events

Specialty Size 33mm Reduced Diameter Reaming Cutter 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-00659-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-05-19
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00659-1
  • 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 discovered that the specialty 33mm cutter outer diameter was designed too large and would thus prevent the device from passing through the specialty clamping barrel. this may result in the surgery time being extended by up to 15 minutes to retrieve and use an alternative readily available instrument.
  • 조치
    Stryker is advising customers to inspect stocks and quarantine any affected units prior to their return to Stryker. This action has been closed-out on 03/02/2017.

Device

Specialty Size 33mm Reduced Diameter Reaming Cutter
  • 모델명 / 제조번호(시리얼번호)
    Specialty Size 33mm Reduced Diameter Reaming CutterCatalogue Number: I-K0913DC33All lots affectedARTG Number: 140892
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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