Events

Various Optetrak Devices - Spine Stiffener Screw and Constrained Condylar (CC) Tibial Insert when used in conjunction with Offset Tibial Tray 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Exactech 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-2017-RN-01273-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-11-07
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01273-1
  • 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
    Exactech initiated a corrective action for the affected catalogue numbers due to a design incompatibility between the optetrak offset spine stiffener screw and the optetrak constrained condylar (cc) tibial insert when used in conjunction with an optetrak offset tibial tray. the optetrak offset spine stiffener screw is offered in a variety of sizes and is used as a secondary means to secure the optetrak constrained condylar (cc) tibial insert to the optetrak offset tibial tray. in all but one combination, the next size optetrak offset spine stiffener screw can be used without any anticipated adverse health consequences. exactech anticipates there may be a slight surgical delay while a larger screw is opened.This action was undertaken prior to consultation with the therapeutic goods administration (tga).
  • 조치
    Exactech has provided users with an updated compatibility chart.

Device

Various Optetrak Devices - Spine Stiffener Screw and Constrained Condylar (CC) Tibial Insert when...
  • 모델명 / 제조번호(시리얼번호)
    Various Optetrak Devices - Spine Stiffener Screw and Constrained Condylar (CC) Tibial Insert when used in conjunction with Offset Tibial TrayMultiple Catalogue Numbers and ProductsAll serial numbers affectedARTG Number: 252474
  • Manufacturer
    Exactech Australia Pty Ltd

Manufacturer

Exactech Australia Pty Ltd