Score Extension Stem for Total Knee Prosthesis - Cemented 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Amplitude 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-00706-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-06-10
  • 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
    Amplitude has become aware through transport simulation tests that the packaging pouches of some devices could be damaged. the pouches function as the sterile barrier of the device packaging. there is a risk of infection if a patient is implanted with a non- sterile implant. the implantation of non-sterile device is unlikely. the routine tests conducted on devices did not show any case of non-sterility and no clinical incident was reported in relation with loss of sterility of the device.
  • 조치
    Amplitude is advising users to inspect stock and quarantine any remaining units of the affected products for return. Patients with implanted devices should be followed up as per standard hospital procedures.

Device

  • 모델명 / 제조번호(시리얼번호)
    Score Extension Stem for Total Knee Prosthesis - CementedMultiple product codes affectedAll lot numbers affectedARTG number: 242001
  • Manufacturer

Manufacturer