Events

CUSA Excel+ Sterile Torque Disposable Wrench (23kHz) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Integra Neurosciences 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-2014-RN-00306-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-03-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00306-1
  • 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
    Integra lifesciences has identified that some lots of 23 khz sterile torque wrenches contain wrenches that will only fit 36 khz cusa handpiece tips. the green colour code and size printed on the wrenches are correct for a 23 khz wrench, but the affected wrench size insert is smaller than it should be and will only fit a 36 khz cusa tip.
  • 조치
    Integra is requesting end users to determine if they have any units from the affected lot. If the outer box has a green dot sticker the torque wrench can be used. If the box does not have a green dot sticker end users are requested to quarantine the unit. An Integra sales representative will arrange for the affected units to be inspected. In the event that an inspection cannot be undertaken in a reasonable time replacement units will be arranged.

Device

CUSA Excel+ Sterile Torque Disposable Wrench (23kHz)
  • 모델명 / 제조번호(시리얼번호)
    CUSA Excel+ Sterile Torque Disposable Wrench (23kHz)Catalogue Number: C5601Lot Numbers: 1132424, 1132883, 1132884, 1133453, 1133454, 1133455, 1134067, 1134675, 1134873, 1135014ARTG Number: 151 502
  • Manufacturer
    Integra Neurosciences Pty Ltd

Manufacturer

Integra Neurosciences Pty Ltd