Events

A.L.P.S. 4.0mm Cancellous Locking Screws (non-sterile)CNCLS LOCK SCREW FT4.0x10mm, 4.0x12mm, 4.0x14mm, 4.0x16mm, 4.0x18mm, 4.0x20mm, 4.0x22mm ,4.0x24mm, 4.0x26mm, 4.0x28mm, 4.0x30mm, 4.0x32mm, 4.0x34mm, 4.0x36mm, 4.0x38mm, 4.0x40mm, 4.0x42mm, 4.0x44mm, 4.0x46mm, 4.0x48mm, 4.0x50mm, 4.0x55mm, 4.0x60mm, 4.0x65mm, 4.0x70mm, 4.0x75mm, 4.0x80mm, 4.0x85mm, 4.0x90mm, 4.0x95mm, 4.0x100mm 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Biomet 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-2015-RN-01162-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-11-30
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01162-1
  • 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
    It has been identified that all lots of a.L.P.S. 4.0mm cancellous locking screws, manufactured between june 1, 2008 and june 4, 2015, have a single lead thread instead of a triple lead thread. a single lead screw may sit proud in the plate which could lead to soft tissue irritation. in addition, if the screw does not lock into the plate, it is possible for the screw to back out. in the event that the screw does not lock into the plate and backs out, a revision surgery may be necessary.
  • 조치
    Zimmer Biomet is advising users to inspect stock and quarantine the affected unused units prior to their return to the sponsor. The sponsor will replace the affected unused units. Patients who have been implanted with the affected units should be monitored by qualified healthcare professional. For more details, please see https://www.tga.gov.au/alert/anatomic-locked-plating-system-4-mm-cancellous-locking-screws-used-treat-broken-bones . This action has been closed-out on 29/08/2016.

Device

A.L.P.S. 4.0mm Cancellous Locking Screws (non-sterile)CNCLS LOCK SCREW FT4.0x10mm, 4.0x12mm, 4.0x...
  • 모델명 / 제조번호(시리얼번호)
    A.L.P.S. 4.0mm Cancellous Locking Screws (non-sterile)CNCLS LOCK SCREW FT4.0x10mm, 4.0x12mm, 4.0x14mm, 4.0x16mm, 4.0x18mm, 4.0x20mm, 4.0x22mm ,4.0x24mm, 4.0x26mm, 4.0x28mm, 4.0x30mm, 4.0x32mm, 4.0x34mm, 4.0x36mm, 4.0x38mm, 4.0x40mm, 4.0x42mm, 4.0x44mm, 4.0x46mm, 4.0x48mm, 4.0x50mm, 4.0x55mm, 4.0x60mm, 4.0x65mm, 4.0x70mm, 4.0x75mm, 4.0x80mm, 4.0x85mm, 4.0x90mm, 4.0x95mm, 4.0x100mmMultiple Part Numbers AffectedAll Lot Numbers AffectedARTG Number: 209305
  • Manufacturer
    Biomet Australia Pty Ltd

Manufacturer

Biomet 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