Events

Tibial Alignment Guide – iAssist Knee System 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-2015-RN-00482-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-06-05
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00482-1
  • 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
    Based upon complaint investigation, zimmer cas has determined that the potential exists for the spikes on the iassist tibial alignment guide to bend or break during insertion or extraction from the tibia during use. the bending or breakage of the spikes is due to a stress riser at the junction of the spike and the main body of the instrument in combination with the presence of repeated high cyclic bending stresses from the impaction method utilized. these stresses are significantly increased when the proper steps of the surgical technique are not followed. although unlikely, if a spike breaks and goes unobserved, there is the possibility of a spike being left in the surgical site. there have not been any complaints for this instrument associated with a spike being left in a patient. product manufactured after may 2014 is not affected as they have a different assembly method of the spike that reduces the risk of fatigue.
  • 조치
    Zimmer is notifying hospitals and surgeons of this issuing and providing instructions on how to minimise the risk of bending or breaking. Further action will be carried out by Stryker pending the availability of replacement units. This action has been closed-out on 07/06/2016.

Device

Tibial Alignment Guide – iAssist Knee System
  • 모델명 / 제조번호(시리얼번호)
    Tibial Alignment Guide – iAssist Knee SystemTibial Alignment Guide Part Number: 20-8011-013-00Lot Numbers: 120265, 120793, 120794, 130135, 130539ARTG Number: 205936
  • 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