Events

Provide Protection Caps and Provide Impression Copings 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-2015-RN-01113-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-11-16
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01113-1
  • 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 determined that the provide protection caps (ppc***) and the provide impression copings (pic***) elicit a cytotoxic response (grade 4). the affected products are intended for single, short-term use. the affected products were also distributed within certain provide abutment placement kits (pak****) as well as within certain provide abutment restorative kits (prk***). both the provide protection caps and the provide impression copings are single-use, temporary devices. if the clinician uses either of these products, the patient may experience soft tissue irritation and discomfort.
  • 조치
    Customers are to inspect stock and quarantine affected units. Affected units should be returned to the sponsor. The sponsor is to confirm that all affected customers have reviewed the recall notice and return credit to the affected customers. This action has been closed-out on 26/08/2016.

Device

Provide Protection Caps and Provide Impression Copings
  • 모델명 / 제조번호(시리얼번호)
    Provide Protection Caps and Provide Impression CopingsProvide Protection CapCatalogueNumber : PPC484, PPC485, PPC654, PPC655All Lots are affectedProvide Impression CopingCatalogueNumber: PIC484, PIC484H, PIC485, PIC485H, PIC654, PIC654H, PIC655, PIC655HAll Lot Numbersare affectedARTG Number: 120308
  • 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