Events

DePuy CMW 2 Gentamicin Bone Cement 20 g 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Johnson & Johnson Medical Pty Ltd 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-2014-RN-00151-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2014-02-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00151-1
  • 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 amount of gentamicin detailed on the unit outer carton label is incorrectly stated as 1.0 m.I.U. (million international units). this should be labelled 0.5 m.I.U. information on the foil pouch and ifu is correct. the composition of the mislabelled bone cement complies with the product specifications and the cement functions according to design intent. the affected lots should be used in the normal manner in accordance with the ifu, and the gentamicin content on the outer carton label for these batches should be disregarded.
  • 조치
    Johnson & Johnson Medical are advising users to continue to follow the Instructions for Use (IFU).

Device

DePuy CMW 2 Gentamicin Bone Cement 20 g
  • 모델명 / 제조번호(시리얼번호)
    DePuy CMW 2 Gentamicin Bone Cement 20 g Part Number: 3325020 Lot Numbers: 3590475, 3607803, 3620321 and 3625505
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd