Events

Comprehensive Nano Humeral Component PPS 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-00789-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-06-27
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00789-1
  • 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 is performing a labelling update for the comprehensive nano humeral component. this product may be used in the anatomic or reverse configuration, however data collected during an annual post market surveillance review, in addition to clinical study data, indicated that the comprehensive nano humeral component did not meet the expected performance rate (epr) when used specifically in the reverse configuration.Due to the comprehensive nano humeral component exceeding the epr when used in the reverse configuration, zimmer biomet is updating the instructions for use (ifu) labelling included with the implant to remove the indication for the reverse configuration.
  • 조치
    Zimmer Biomet is requesting Customers: 1. Review this notification for awareness of the contents; 2. Immediately stop using the affected items in the reverse configuration; usage in the anatomic configuration is permitted in accordance with the current Instructions for Use; 3. There are no specific patient monitoring instructions related to this recall for product correction that are recommended beyond the existing follow up schedule; 4. Complete the supplied Attachment 1 – Certificate of Acknowledgement. 5. Return a digital copy to RAQA.ANZ@zimmerbiomet.com Retain a copy of the Acknowledgement Form with your field action records in the event of a compliance audit of your documentation.

Device

Comprehensive Nano Humeral Component PPS
  • 모델명 / 제조번호(시리얼번호)
    Comprehensive Nano Humeral Component PPSItem Numbers:115730 (Size 30mm)115732 (Size 32mm)115734 (Size 34mm)115736 (Size 36mm)115738 (Size 38mm)115740 (Size 40mm)ARTG Number: 220712
  • 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