Events

3R62 Pheon Modular Knee Joint (External leg prosthesis) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Otto Bock 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-01512-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2016-11-22
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01512-1
  • 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
    It has been found that the locking function may fail under certain conditions. the activation locking can only be activated by the clinician prior to the fitting of the device. the units that have been supplied in australia do not have the locking mechanism activated. please note that when the locking mechanism is set as non-active, the device poses no safety risk to the patient. however, it is possible that in the course of time the patient’s physical condition may require the locking function to be activated.
  • 조치
    Otto Back is advising clinicians to contact patients who have been fitted with the affected device for a replacement with the new version.

Device

3R62 Pheon Modular Knee Joint (External leg prosthesis)
  • 모델명 / 제조번호(시리얼번호)
    3R62 Pheon Modular Knee Joint (External leg prosthesis)Serial Numbers: 201447012, 201512056, 201517011ARTG Number: 113606
  • Manufacturer
    Otto Bock Australia Pty Ltd

Manufacturer

Otto Bock Australia Pty Ltd