Synthes VEPTR® Vertical Expandable Prosthetic Titanium Rib 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Synthes 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
    18970
  • 사례 시작날짜
    2015-08-18
  • 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: Johnson & Johnson (NZ) Limited, 13a Gabador Place, Mt Wellington, AUCKLAND
  • 원인
    The last hole on certain veptr caudal rib supports may be partialy formed. fully lengthening the construct to the partially formed last hole may result in mechanical failure of the construct due to extension bar breakage, which could require unplanned surgical intervention to exchange components.
  • 조치
    Product to be returned to supplier

Device

  • 모델명 / 제조번호(시리얼번호)
    Model: 497.087, 497.088, 497.089, 497.241, 497.242, 497.243, 497.093, 497.094, 497.095, 497.244, 497.245, 497.246, 497.098, 497.099, 497.100, 497.247, 497.248, 497.249, and 497.225 to 497.239 inc., Affected: Selected lots
  • Manufacturer

Manufacturer