Events

Trauma Implants - intramedullary nailsZ NAIL PF 14mm x 46cm UNIV 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-00634-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-05-16
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00634-1
  • 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 sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures. specifically, multiple test samples from the configuration failed simulated distribution and shipping testing. it is very likely that any damage to the carton box and/or to the outer tray would be detected prior to surgery. the package insert (instructions for use) provided with the device or device system contains a section on sterility. it instructs the user to inspect the package and not use the device if any seal or cavity is damaged. if compromised packaging is detected during surgery, it may result in a slight delay in surgery to obtain another implant. in the unlikely event that compromised packaging is not detected prior to or during surgery by the user, there is a risk of infection.
  • 조치
    Users are advised to assist their Zimmer Biomet sales representative to quarantine all affected product. There are no specific patient monitoring instructions related to this recall that are recommended beyond the surgeons existing surgical follow up protocol.

Device

Trauma Implants - intramedullary nailsZ NAIL PF 14mm x 46cm UNIV
  • 모델명 / 제조번호(시리얼번호)
    Trauma Implants - intramedullary nailsZ NAIL PF 14mm x 46cm UNIVItem Number: 47-2491-460-14Z NAIL GT 14mm x 46cm RItem Number:47-2492-460-14 Z NAIL GT 14mm X 46cm LItem Number: 47-2492-461-14All Lot Numbers with an expiry date before May 2027ARTG Number: 169891
  • 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