Events

"PROFEMUR R" PROX BODY PLASMA SPRAYSTD3 (femoral component of a hip joint prosthesis) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Wright Medical Australia 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-2012-RN-01062-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2012-11-15
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01062-1
  • 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 recall is being initiated because there is a label discrepancy that affects the shelf life listed on products manufactured at the toulon, france facility. the product functions as intended, however there is not adequate justification on file to support the packaging shelf life listed on the label. there have been no reported issues related to the packaging integrity or sterility of this product. this recall is being initiated because there is a potential risk to health (such as contamination/infection) that may arise if a packaging integrity failure were to occur.
  • 조치
    Wright Medical advises devices implanted are considered safe and are not required to be revisited.

Device

"PROFEMUR R" PROX BODY PLASMA SPRAYSTD3 (femoral component of a hip joint prosthesis)
  • 모델명 / 제조번호(시리얼번호)
    "PROFEMUR R" PROX BODY PLASMA SPRAYSTD3 (femoral component of a hip joint prosthesis)Product code: PPW38363Lot Number: X02382954ARTG Number: 154282
  • Manufacturer
    Wright Medical Australia Pty Ltd

Manufacturer

Wright Medical Australia Pty Ltd