Events

8mm Vector TAS Screw and Vector TAS Starter Kit (Orthodontic anchoring screw) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Ormco 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-2013-RN-00775-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-08-07
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00775-1
  • 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
    Ormco have found that some screws in the affected lot were machined undersized at the top of the threads may potentially cause a weakening of the screw. use of the undersized product may result in breakage of the screw during insertion or removal when torqued, possibly requiring surgical removal of any remaining pieces.
  • 조치
    Customers are asked to return any of the affected stock remaining in the inventory. Ormco is advising users to continue with normal treatment if the 8 mm screw is believed to have already been placed or in treatment. When the screw is ready to be removed, physicians are requested to take special care and to not over-torque the screw on removal. For more details, please see http://www.tga.gov.au/safety/alerts-device-8mmvectorscrew-130809.htm .

Device

8mm Vector TAS Screw and Vector TAS Starter Kit (Orthodontic anchoring screw)
  • 모델명 / 제조번호(시리얼번호)
    8mm Vector TAS Screw and Vector TAS Starter Kit (Orthodontic anchoring screw)8mm Vector TAS ScrewPart Number: 601-0021Lot Number: 112911Vector TAS Start Kit (10 patient)Part Number: 601-0010Lot Number: 112911 (8mm screws from within the kit)ARTG Number: 145039
  • Manufacturer
    Ormco Pty Ltd

Manufacturer

Ormco Pty Ltd