Events

Xia 3 Titanium Torque Wrench 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-00745-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-08-17
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00745-1
  • 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 reports that the hex tip of the listed torque wrenches have been fracturing during final tightening. the hex tip of the wrench has broken off and separated from the main tube.The manufacturer has identified four possible hazardous situations:· delay in surgery time (< 5 minutes) if an alternative torque wrench is needed· debris of non-implantable grade material falling into the wound· over/under-tightening of the blocker if an alternate instrument is not available· accidental implanting of the hex tip.
  • 조치
    Customers are requested to quarantine all affected lots. A Stryker representative will contact all affected customers to arrange for collection of the affected products. Unaffected replacement units will be provided. This action has been closed-out 18/04/2017.

Device

Xia 3 Titanium Torque Wrench
  • 모델명 / 제조번호(시리얼번호)
    Xia 3 Titanium Torque WrenchCatalogue Number: 48237028Lot Numbers: 098525, Xia 3 Torque Wrench ShortCatalogue Number: 482397028Lot Numbers: 11E035ARTG Number: 160151
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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