Events

HP LCS IM HOLE LOCATOR INSTRUMENT 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC. 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
    105168
  • 사례 위험등급
    II
  • 사례 시작날짜
    2015-01-29
  • 사례 국가
    Canada
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • 데이터 추가 비고
  • 원인
    Depuy orthopaedics is issuing a device correction for all lots of hp lcs intramedullary (im) hole locator instruments because the japanese market has reported eight instances where femoral fractures occurred intra-operatively during primary knee replacement surgery while using the instrument. the company is not requesting the return of the device. this communication is to highlight and expand upon information from the appropriate surgical technique which states that the device may be lightly impacted for additional stability.

Device

HP LCS IM HOLE LOCATOR INSTRUMENT

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.