Events

Modular Finishing Instrument Tray Assembly (used to store, transport and organise instrumentation for the Restoration Modular Instruments Set) 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-01246-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-11-22
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01246-1
  • 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 the trays of the affected lot number are missing two of the four necessary cut outs. these cut outs provide clearance to secure the clips on the tray lid to the base. the hazard identified is the potential for the blue wrap to tear as a result of the protruding unsecured clips, making the contents of the tray unsterile. a potential tear would likely be noticed by the surgical staff before the instrument is used as the blue wrap is checked for any defects prior to surgery.
  • 조치
    Stryker is advising users to remove any affected trays from use. Any affected trays will the replaced by Stryker.

Device

Modular Finishing Instrument Tray Assembly (used to store, transport and organise instrumentation...
  • 모델명 / 제조번호(시리얼번호)
    Modular Finishing Instrument Tray Assembly (used to store, transport and organise instrumentation for the Restoration Modular Instruments Set)Catalogue Number: 62789970Lot Number: 039980ARTG Number: 140892
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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