Events

Various Trauma and Extremity Instruments (drill bits, screw taps and saw blades) 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-00910-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-07-26
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00910-1
  • 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 discovered a raw material anomaly during an inspection of various trauma and extremity instruments (drill bits, screw taps and saw blades). an investigation by the supplier determined that four lots of raw material could have similar anomalies. the anomaly has the potential to be on or below the surface and can increase the risk of instrument fracture. the affected units were distributed between the dates of march 2016 and may 2017.This issue may lead to extension of surgery < 30 minutes and/or the patient retains piece of fractured instrument leading to patient injury.This issue is not visually detectable in all cases. one injury has been reported internationally.
  • 조치
    Zimmer Biomet is conducting a lot specific recall for various trauma and extremity instruments (drill bits, screw taps and saw blades). Hospital Responsibilities: 1.Review this notification and ensure affected personnel are aware of the contents; 2.Assist the Zimmer Biomet sales representative quarantine all affected product; 3.The Zimmer Biomet sales representative will remove the affected product from your facility; 4.Complete the supplied Attachment 1 – Certificate of Acknowledgement; a.Return a digital copy to RAQA.ANZ@zimmerbiomet.com b.Retain a copy of the Acknowledgement Form with your field action records in the event of a compliance audit of your facilities documentation.

Device

Various Trauma and Extremity Instruments (drill bits, screw taps and saw blades)
  • 모델명 / 제조번호(시리얼번호)
    Various Trauma and Extremity Instruments (drill bits, screw taps and saw blades)Multiple Item and Lot NumbersARTG Numbers: 112735 and 209302
  • 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