Events

NC and RC screw for Cares Abutment, Zr02 and IFU NC Screw for CARES® Abutment, Zr02 and IFU; article 022.2630RC Screw for CARES® Abutment, Zr02 and IFU; article 022.4630 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Straumann 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-2012-RN-00757-3
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2012-08-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00757-3
  • 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
    A customer complaint reports that the article 022.2630 nc screw for cares® abutment, zr02 and ifu contains an incorrect screw. the investigation has confirmed that there has been a mix-up and a limited number of articles 022.2630 nc screw for cares® abutment, zr02 and ifu incorrectly contain an rc screw and 022.4630 rc screw for cares® abutment incorrectly contain an nc screw. all of the affected lots are identified and stopped further shipment however the invesitgation indicates that these incorrect screws have been shipped in 9 cases 027.4650 cares® abutment set rc, ceramic and 87 cases 027.2650 cares® abutment set nc, ceramic and dental laboratory.This recall action was not notified to the tga before it was initiated by straumann pty ltd.
  • 조치
    Quarantine and return affected product to the distributors.

Device

NC and RC screw for Cares Abutment, Zr02 and IFU NC Screw for CARES® Abutment, Zr02 and IFU; arti...
  • 모델명 / 제조번호(시리얼번호)
    NC and RC screw for Cares Abutment, Zr02 and IFU NC Screw for CARES® Abutment, Zr02 and IFU; article 022.2630RC Screw for CARES® Abutment, Zr02 and IFU; article 022.4630
  • Manufacturer
    Straumann Pty Ltd

Manufacturer

Straumann Pty Ltd