Events

iASSIST Validation Tool 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Zimmer Biomet 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-2017-RN-00397-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-03-31
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00397-1
  • 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 manufacturer has received an increased number of complaints regarding bent or broken drive pins of the iassist validation tool manufactured with drawing revision m to p. breakage of the drive pin or drive pin head will lead to the parts having to be retrieved and hence, a delay in treatment.Only iassist validation tools with drawing revision m to p drive pins are affected (they have a x cross section instead of circular and the drive pin head has a recess in the enlarged head).
  • 조치
    Zimmer Biomet is advising surgeons that the affected products can continue to be used until replacements are available. In the interim, the Knee Surgical Technique (2-Pod Version) (Ref. 97-9001-004-00 Rev 2) and specifically the warning on pages 36 and 37 regarding applying excessive force, should be followed in order to minimize the chances of bending or breakage during use. In addition, surgeons should inspect affected devices before and immediately after use to confirm that the drive pins are not bent or broken. In the event of breakage, the drive pin head will disassemble and therefore surgeons should ensure that both parts are retrieved from the wound.

Device

iASSIST Validation Tool
  • 모델명 / 제조번호(시리얼번호)
    iASSIST Validation ToolModel Number: 20-8011-021-00 Rev M-PARTG Number: 205936
  • Manufacturer
    Zimmer Biomet Pty Ltd

Manufacturer

Zimmer Biomet 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