Events

Nobel Replace Conical Connection PMC RP 5.0x13mm( Fully Imbedded Dental Implant – Screw endosteal) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Nobel Biocare 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-00302-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2015-04-02
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00302-1
  • 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
    Nobel biocare quality management systems observed an issue with a material used in the packaging of the implants. the packaging component (cap) showed excessive oil which was caused by an issue in production of the raw material (pellets) for manufacturing the caps. nobel biocare's internal analysis has confirmed that this material is not according to the standards. based on the testing performed so far the likelihood that the products cause adverse health consequences is currently considered to be low. the implant batches still at the manufacturing site were restricted for further distribution and placed in quarantine.
  • 조치
    Nobel Biocare requested the customer to return the affected product with batch number 13010296. Nobel Biocare is providing a replacement product. This action was underatken prior to notifying TGA.

Device

Nobel Replace Conical Connection PMC RP 5.0x13mm( Fully Imbedded Dental Implant – Screw endosteal)
  • 모델명 / 제조번호(시리얼번호)
    Nobel Replace Conical Connection PMC RP 5.0x13mm( Fully Imbedded Dental Implant – Screw endosteal)Batch number: 13010296Article number: 37298ARTG Number: 202090
  • Manufacturer
    Nobel Biocare Australia Pty Ltd

Manufacturer

Nobel Biocare Australia Pty Ltd