Events

Application Instrument for Sternal ZipFix 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Synthes 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-2013-RN-00924-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-09-03
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00924-1
  • 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
    There is potential for zipfix implants to loosen if the implant is cut while the tensioning trigger is being squeezed. implants cut under tension can cause deformations in the teeth of the locking mechanism thereby compromising the integrity of the implants. the possibility exists for the zipfix implant to be compromised and loosen after implantation or during the post operative recovery period.
  • 조치
    Customers are requested to contact their local Sales Consultant to arrange for replacement with a 2nd generation Application Instrument. DePuy Synthes has confirmed that all 1st generation applicators in loan sets will be replaced with 2nd generation applicators.

Device

Application Instrument for Sternal ZipFix
  • 모델명 / 제조번호(시리얼번호)
    Application Instrument for Sternal ZipFixPart Number: 03.501.080Lot Number: All 1st generation Application Instruments - Lots prior to 8100630ARTG Number: 153950
  • 의료기기 분류등급
    Orthopedic Devices
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd