Events

DePuy S-ROM Noiles Rotating Hinge Femur with Pin 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Johnson & Johnson Medical Pty Ltd T/A Depuy Australia 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-00939-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-08-27
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00939-1
  • 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
    In march, 2014, johnson & johnson medical pty. ltd (jjm) issued recall for product correction letter (tga ref.: rc-2014-rn-00355-1) for the s-rom noiles rotating hinge femur with pin devices as the company had identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for both the femur and the hinge pin. the new packaging design is complete and products are available with the new packaging. therefore, johnson & johnson medical pty ltd is recalling the products with the previous packaging from the market.
  • 조치
    Customers are advised not to use the affected inventory. Replacement product with the new packaging will be supplied for the affected stock. This action has been closed-out on 06/06/2016.

Device

DePuy S-ROM Noiles Rotating Hinge Femur with Pin
  • 모델명 / 제조번호(시리얼번호)
    DePuy S-ROM Noiles Rotating Hinge Femur with Pin Product Codes: 623401L, 623401R, 623411L, 623411R, 623421L, 623421RAffected lots: 314827, 464645, 438249 & 378650ARTG number: 219088
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd T/A Depuy Australia

Manufacturer

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia