Events

Threaded Reduction Tool, 2.4mm diameter, self-drilling, 78mm length, with Hexagonal coupling 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Synthes 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-2014-RN-00354-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-03-24
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00354-1
  • 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 product for this particular lot (3632704) was distributed with "not for human use" etched on the side of the tool. the etching was intended to indicate that the devices were for training purposes only. if the "not for human use" etching on the threaded reduction tool is discovered prior to its use on the patient, but in the operative theatre, it could lead to a small surgical delay until a replacement product is procured.Synthes has advised that if the product was used in an operation, the threaded reduction tool would work as intended and the patient would not be exposed to any increased risk.
  • 조치
    End users are requested to immediately isolate any devices from the affected lot. Affected devices are to be returned to Synthes Australia.

Device

Threaded Reduction Tool, 2.4mm diameter, self-drilling, 78mm length, with Hexagonal coupling
  • 모델명 / 제조번호(시리얼번호)
    Threaded Reduction Tool, 2.4mm diameter, self-drilling, 78mm length, with Hexagonal couplingPart Number: 03.507.002SLot Number: 3632704ARTG Number: 155807
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd