Events

A-642100 fixed offset adaptor (used in external prosthesis) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Ossur Asia-Pacific 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-2013-RN-01236-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-11-21
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01236-1
  • 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 manufacturer has received reports of the affected devices developing fatigue cracks in normal use over an extended period of time and may ultimately separate. since there is hardly any visible or audible sign indicating potential breakage, ossur strongly recommends the retrieval of all components in the field. no injuries resulting from such a failure have been reported and this is a precautionary step.This recall action was carried out prior to the approval of the recall strategy by the tga.
  • 조치
    Ossur is recommending patients have the affected component replaced with a different component, and return any remaining inventory to Ossur.

Device

A-642100 fixed offset adaptor (used in external prosthesis)
  • 모델명 / 제조번호(시리얼번호)
    A-642100 fixed offset adaptor (used in external prosthesis)All units sold since 1 January 2008
  • Manufacturer
    Ossur Asia-Pacific

Manufacturer

Ossur Asia-Pacific