Events

Vanguard Open Box Posterior Stabilised Femoral Components 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-00984-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-08-10
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00984-1
  • 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 biomet has identified an issue with vanguard open box posterior stabilised femoral components where inadequate line clearance at the supplier between 5 april 2016 and 1 september 2016. as a result, the packaging of some femoral components was incorrectly labelled as either smaller or larger and/or as the incorrect side (right/left). it is highly detectable at the point of use that the device was incorrectly labelled. the estimated rate of occurrence is <1 in 1,000 products.
  • 조치
    Zimmer is requesting surgeons: 1. Review the notification and ensure affected personnel are aware of the contents; 2. Complete the Certificate of Acknowledgement supplied with the customer letter, then a. Return a copy to RAQA.ANZ@zimmerbiomet.com; and b. Retain a copy of the Acknowledgement Form with your field action records in the event of a compliance audit of your facilities documentation. 3. If after reviewing this notice there are further questions or concerns please contact the local Zimmer Biomet representative.

Device

Vanguard Open Box Posterior Stabilised Femoral Components
  • 모델명 / 제조번호(시리얼번호)
    Vanguard Open Box Posterior Stabilised Femoral ComponentsItem Number :183106Lot Number: J3842173Item Number: 183106Lot Number: J3844489ARTG Number: 218510
  • 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