Events

Straumann dental surgical drills 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-2016-RN-01543-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-11-30
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01543-1
  • 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
    The investigation of a received complaint has confirmed that the shaft diameter of a drill article number 044.215 lot lv457 is greater than the defined specification of ø2.35mm in the area of the laser marking on the shaft. further investigation has shown that the further articles and lots are also impacted. testing with different handpieces shows that the drills can be inserted. however, depending on the manufacturing tolerances of the handpiece that is used, these drills may not fit. if the drills do not fit into the handpiece and there is not an alternative instrument available, then the the planned treatment would need to be re-scheduled.
  • 조치
    Straumann has advised customers to check their inventory for affected product and return all stock. Straumann will provide replacements. This action has been closed-out on 09/06/2017.

Device

Straumann dental surgical drills
  • 모델명 / 제조번호(시리얼번호)
    Straumann dental surgical drillsDrill 1, short, Ø 2.2mm, l 33.0mm, SSArticle #: 044.210 Lot #: MG783Component # Number (on drill): LZ239Twist Drill PRO Ø4.2mm,long,41mm,SSArticle #: 044.255 Lot #: LV455Component Lot # (on drill): LF828 ARTG Number: 119314
  • Manufacturer
    Straumann Pty Ltd

Manufacturer

Straumann Pty Ltd