Events

Ankle Arthrodesis Nail 611AFN Drill Bit 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Tornier 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-2017-RN-00680-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-06-06
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00680-1
  • 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
    Despite being guided by drill reference mju775, cases of drill breakage during surgery have been received by wright medical australia. this issue has been replicated by the manufacturer in internal tests. breakage of the tip of the drill during use may lead to the need to remove debris and a delay in surgery.
  • 조치
    Wright Medical is advising users that in order to optimize the drilling technique, there will be a modification to the cutting edge of the drill. Users will be contacted for the return and exchange when replacements become available (from November 2017). In the interim, users are advised to apply the drilling force in the axis of the drill (as illustrated in the recall notification).

Device

Ankle Arthrodesis Nail 611AFN Drill Bit
  • 모델명 / 제조번호(시리얼번호)
    Ankle Arthrodesis Nail 611AFNDrill Bit Model Number: MJU777Lot Numbers 11D463 and 12E794ARTG Number: 112287
  • Manufacturer
    Tornier Pty Ltd

Manufacturer

Tornier Pty Ltd