Events

System 6 Aseptic Battery Kit 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-2015-RN-00049-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-01-20
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00049-1
  • 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
    The system 6 aseptic battery kit provides a sterile enclosure for the styker non-sterile battery. the manufacturer has identified the affected lot to have insufficient bond strength at a weld joint associated with the aseptic housing, due to an issue during manufacture. therefore, the quality of the weld may not be as effective as intended. this could lead to the separation of the top section of the housing from the bottom section. this may lead to sterility breaches, loss of surgical control, intra-operative complications and potential delays in surgery.
  • 조치
    Affected units will be replaced via the standard stock replenishment process. This action has been closed-out on 18/08/2016.

Device

System 6 Aseptic Battery Kit
  • 모델명 / 제조번호(시리얼번호)
    System 6 Aseptic Battery Kit Catalogue: 6126-120-000Lot Numbers: 1312, 13210, 13209ARTG Number: 152526
  • 의료기기 분류등급
    Orthopedic Devices
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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