Events

MENTOR Gel Sizers (Sizer for mammary prosthesis) 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-00600-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-06-04
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00600-1
  • 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
    A complaint was received for a volume discrepancy between the pad print (500cc) and laser engraved marking and all other product labelling (550cc) on a mentor gel sizer manufactured at mentor leiden. during the bounding investigation, a second lot was identified as having a style discrepancy between pad print (moderate profile, mp) and all other product labelling (moderate plus, m+). misjudging the size or style of an implant can result in asymmetric outcome, which may need additional surgery.
  • 조치
    Johnson & Johnson Medical (JJM) is requesting their customers to quarantine the affected stock immediately. Arrangements to return the product can be made by contacting the JJM customer service.

Device

MENTOR Gel Sizers (Sizer for mammary prosthesis)
  • 모델명 / 제조번호(시리얼번호)
    MENTOR Gel Sizers (Sizer for mammary prosthesis)Product Code: RSZ5501 Lot Number: 6680501Product Code: RSZ2751Lot Number: 6749298ARTG Number: 157489
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd