Events

3i T3, Full Osseotite Tapered & Parallel Walled Dental Implants 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-2014-RN-01222-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-12-02
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01222-1
  • 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
    Biomet 3i has identified a visually observable condition which may be present on a limited number of the identified implants. the condition is caused by the implant coming into contact with residual machining fluid which was not adequately degreased from a portion of 1 lot of packaging cylinders. the residual machining fluid causes the implants to be discoloured. biomet 3i has determined that there are no known health effects of the residue. this has been confirmed through cytotoxicity and endotoxicity tests, which have yielded negative results for toxins on residue-affected samples.
  • 조치
    No affected units are known to have been implanted in Australia. Customers are advised to return affected products to BIOMET 3i Australia Pty Ltd for replacement with unaffected units. This action has been closed-out on 14/07/2016.

Device

3i T3, Full Osseotite Tapered & Parallel Walled Dental Implants
  • 모델명 / 제조번호(시리얼번호)
    3i T3, Full Osseotite Tapered & Parallel Walled Dental Implants3i T3 Non-Platform Switched Tapered Implant 3.25X8.5 -15.0mmCatalog Number BOST3211Lot Numbers: 2014051395 (Expiry: 12/11/2018), 2014051817 (Expiry: 12/09/2018)Full Osseotite Certain Implant 3.25X8.5 - 15.0mmCatalog Number XIFNT3211 Lot Number 2014051477 (Expiry: 12/06/2018)Parallel Walled Certain 2 Implant 3.25X8.5 - 18mmCatalog Number: XIFOSM311Lot Number: 2014051368 (Expiry: 12/03/2018)ARTG Number100482
  • 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