Events

Trident Tritanium Acetabular Window Trials Case 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-2013-RN-01356-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-12-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01356-1
  • 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 become aware that some outer trays of the trident tritanium acetabular window trials case have case handles which were installed upside-down, thus blocking 2 of the 4 slots that allow clips to secure the lid to the case. the hazard identified is the potential for the blue wrap to tear as a result of the protruding unsecured clips making the contents unsterile. note that the plastic tray insert and instrument contents of this tray are not affected by this issue and may continue to be used independently of the outer tray.
  • 조치
    Stryker is requesting their customers to inspect and quarantine any units from the affected lot. A Stryker representative will arrange for the return of any affected product.

Device

Trident Tritanium Acetabular Window Trials Case
  • 모델명 / 제조번호(시리얼번호)
    Trident Tritanium Acetabular Window Trials CaseCatalogue Number: 24024020Lot Number: 032173ARTG Number: 140892
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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