Otto Bock 4R82 Tube Clamp Adapter 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Otto Bock Healthcare GmbH 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
    13187
  • 사례 시작날짜
    2012-07-23
  • 사례 국가
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Ottobock Australia Pty, Suite 1.01 Century Corporate Centre, 62 Norwest Boulevarde, Baulkham Hills, NSW 2153, AUSTRALIA
  • 원인
    The manufacturer received some complaints about adapters that show a crack starting at the clamping of the adapter into direction of the clamping slot. due to the crack, the clamping to the tube adapter is lost and the prosthesis twists when loaded. depending on the situation this may cause the patient to fall.
  • 조치
    Product to be returned to supplier

Device

  • 모델명 / 제조번호(시리얼번호)
    Model: 4R82, Affected: Lots manf between Nov-2011 and Mar-2012
  • Manufacturer

Manufacturer