Events

Aequalis Reversed II and Reversed Fracture Impactors (supplied as part of Aequalis Reversed II and Reversed Fracture Instrument sets, YKAD83 &YKAD95;) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Tornier 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-01035-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-10-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01035-1
  • 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
    Following the identification of the disassociation of an impactor tip during a surgery, without any clinical consequences for the patient, tornier has initiated recall of all lots of aequalis reversed ii and reversed fracture impactors (items number mwd021, mwd023, mwd024, mwd025). upon review of the event, tornier determined that a redesign of the instrumentation was warranted.This recall action was carried out prior to approval by the therapeutic goods administration.
  • 조치
    In the interim the manufacturer (Tornier SAS) has recommended an alternative method using other impactors that are available in other Tornier shoulder instrument sets. Tornier has issued a specific operative technique to explain which impactor to be used. The replacement with new impactors has begun.

Device

Aequalis Reversed II and Reversed Fracture Impactors (supplied as part of Aequalis Reversed II an...
  • 모델명 / 제조번호(시리얼번호)
    Aequalis Reversed II and Reversed Fracture Impactors (supplied as part of Aequalis Reversed II and Reversed Fracture Instrument sets, YKAD83 &YKAD95;)Aequalis Reversed II Insert Impaction HandleItem Number: MWD021Aequalis Reversed II Insert Impactor TipItem Number: MWD023Hemiprosthesis Adaptor Impactor TipItem Number: MWD024Aequalis Reversed II Anatomic Head Impactor TipItem Number: MWD024ARTG Number: 112287
  • Manufacturer
    Tornier Pty Ltd

Manufacturer

Tornier Pty Ltd