Events

Universal Clamp System and UniWallis System (used during spinal cord surgery) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Zimmer 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-2016-RN-00232-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-03-08
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00232-1
  • 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
    Zimmer is initiating a recall for product correction to provide updated cleaning, disinfection and sterilisation instruction for use of universal clamp system (ifu, reference: sn2027-n-90001 and uniwallis system (ifu, references: 038wnan0000t). since the market launch of each products (universal clamp system and uniwallis system), the instruments were distributed with instruction for use related to the method for cleaning, disinfection and for steam sterilisation at health care facilities. however, the method was not adequately validated. instruments cleaned, disinfected, and sterilised under the former ifu for the universal clamp and/or uniwallis systems may not be sterile which can result in infection.
  • 조치
    Zimmer is providing users with revised Instructions for Use and advising users to discard the previous IFU.

Device

Universal Clamp System and UniWallis System (used during spinal cord surgery)
  • 모델명 / 제조번호(시리얼번호)
    Universal Clamp System and UniWallis System (used during spinal cord surgery)All lot numbers affectedARTG Number:157602
  • Manufacturer
    Zimmer Pty Ltd

Manufacturer

Zimmer Pty Ltd
  • 제조사 모회사 (2017)
    Zimmer Biomet Holdings
  • 제조사 의견
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    DHTGA