Salfo Talaris Tibial ImpactorPart Number: MJU361 (This instrument is also part of the Salto Talaris Instrumentation, Part Number YKAL13) 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-2014-RN-00971-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-09-18
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    Complaints have been received which describe a non-optimum grip of tibial inserts with the tibial impactor salto talaris which could lead to the fall of the implant. tornier's investigations have led to the conclusion that only sizes 0 and 1 of the tibial implant are not sufficiently maintained by the tibial impactor which, however, remains functional.
  • 조치
    Tornier advised their customers that even if the impactor does not ensure optimal holding of sizes 0 and 1 only of the tibial implant, it can still safely be usedand requested that care be taken when using the device for implantation of sizes 0 and 1 of the tibial implants. Tornier is redesigning the device and will notify customers once complete.

Device

  • 모델명 / 제조번호(시리얼번호)
    Salfo Talaris Tibial ImpactorPart Number: MJU361 (This instrument is also part of the Salto Talaris Instrumentation, Part Number YKAL13)Serial Numbers: 30, 152ARTG Number: 112287
  • Manufacturer

Manufacturer