Events

Stryker Prosthesis knee femoral component 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Stryker Howmedica Osteonics 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
    13559
  • 사례 시작날짜
    2012-10-04
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 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: Stryker New Zealand Ltd, 515 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • 원인
    Manufacturer has become aware of potential packaging issue associated with various products. initial inspections of some items (as listed) revealed what the manufacturer refers to as “creep”. this is when the sterile barrier surface area decreases. at this point, no units have been found to have a full breach of the seal., technical and medical assessments are currently underway to determine any potential hazards associated with the use of the product. all product to be returned to the manufacturer.
  • 조치
    Product to be returned to supplier

Device

Stryker Prosthesis knee femoral component

Manufacturer

Stryker Howmedica Osteonics
  • 제조사 모회사 (2017)
    Stryker
  • Source
    NZMMDSA