Events

Persona Distal Valgus Alignment Guide (supplied as part of the reusable surgical kit) 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-2014-RN-01028-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-09-26
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01028-1
  • 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 has received complaints related to binding of the distal valgus alignment guide's locking knob. persona distal valgus alignment guide collet locks are seizing in the 'unlocked' position during normal operation. this seizure causes the diameter between the collet pegs to become smaller than that of the 8mm im (intramedullary) rod and prevents the rod from being inserted or removed from the alignment guide rendering the device unusable. the root cause of the binding was determined to be excessive counter-clockwise rotation of the knob when unlocking the device.
  • 조치
    Zimmer determined that additional guidance on the locking/unlocking feature was needed. Zimmer is requesting the customers to review the updated portion of the Persona surgical technique (97-5026-001-00) provided with the customer letter, which details use of the Adjustable Valgus Guide. This action has been closed-out on 07/06/2016.

Device

Persona Distal Valgus Alignment Guide (supplied as part of the reusable surgical kit)
  • 모델명 / 제조번호(시리얼번호)
    Persona Distal Valgus Alignment Guide (supplied as part of the reusable surgical kit)Item number: 42-5099-004-00ARTG number: 109936
  • 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