Events

RHD2.5 Hex Driver, 2.5mm with GemLock Retention, contained within TSVKIT Surgical Kit 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Biomet 3i Australia 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-01320-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-11-01
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01320-1
  • 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 that the 2.5mm gemlock hex driver, rhd2.5 contained within a surgical kit may contain a manufacturing anomaly affecting the geometry of the driver’s hex feature, which prevents it from properly engaging with mating components. the rhd2.5 hex driver is used to carry and drive the implant into the osteotomy by connecting to the fixture mount/transfer or directly to the implant. two instruments, rh2.5 and rh2.5l, may be utilised as alternatives to the rhd2.5.
  • 조치
    Zimmer Biomet is advising customers to review their inventory and return affected drivers. Please note that this recall is specific to the hex driver and as such there is no need to return entire surgical kit. Zimmer Biomet will provide replacement RHD2.5 hex drivers to affected customers upon return of affected RHD2.5 hex drivers. Two instruments, RH2.5 and RHL2.5 may be utilised as alternatives to the RHD2.5.

Device

RHD2.5 Hex Driver, 2.5mm with GemLock Retention, contained within TSVKIT Surgical Kit
  • 모델명 / 제조번호(시리얼번호)
    RHD2.5 Hex Driver, 2.5mm with GemLock Retention, contained within TSVKIT Surgical KitSurgical KitItem Number: TSVKITLot Number: 63666560UDI Number: (01)00889024019614(10)63666560ARTG Number: 126570 (Biomet 3i Australia Pty Ltd - Dental implant suprastructure device, temporary)
  • Manufacturer
    Biomet 3i Australia Pty Ltd

Manufacturer

Biomet 3i Australia 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