Universal Impactor/Positioner (used to introduce and extract compatible universal window trials and acetabular cups into the prepared acetabulum during total hip arthroplasty) 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-2016-RN-01137-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-08-26
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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 orthopaedics has received reports of the thread length protruding past the dome of the acetabular trial or implant. upon investigation, it was determined that the press fit between the threaded stud and the handle shaft assembly for the trident universal impactor/positioner may lead to the gradual protrusion of the threaded stud over time. this may result in a delay in surgery, fracture or pain associated with the implant loosening.
  • 조치
    Stryker is advising users to inspect inventory and quarantine affected product for return. This action has been closed out on 16 June 2017.

Device

  • 모델명 / 제조번호(시리얼번호)
    Universal Impactor/Positioner (used to introduce and extract compatible universal window trials and acetabular cups into the prepared acetabulum during total hip arthroplasty)Item Number: 2101-0200Multiple Lot Numbers affectedARTG Number: 140892
  • Manufacturer

Manufacturer

  • 제조사 모회사 (2017)
  • Source
    DHTGA