Events

LPS (Limb Preservation System) Lower Extremity Dovetail Intercalary Component (internal femoral component) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Johnson & Johnson Medical Pty Ltd T/A Depuy Australia 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-00735-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-07-30
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00735-1
  • 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 lps lower extremity dovetail intercalary component has the potential for the female component to fracture when exposed to certain physiological loads.
  • 조치
    Johnson & Johnson Medical is not recommending prophylactic treatment in the absence of symptoms. Surgeons are recommended to review each patient’s case to determine the best treatment options, considering the patient’s weight, activity level and/or any other potential contributing factors. If a patient presents with a fractured LPS Lower Extremity Dovetail Intercalary component with well-fixed proximal and distal stems and the surgeon determines that the LPS Lower Extremity Dovetail Intercalary component is the best treatment option, the company will make the LPS Lower Extremity Dovetail Intercalary component available. For more details, please see http://www.tga.gov.au/safety/alerts-device-limb-preservation-system-130805.htm .

Device

LPS (Limb Preservation System) Lower Extremity Dovetail Intercalary Component (internal femoral c...

Manufacturer

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia