Events

Dynamic Locking Screw Stardrive 3.7mm self tapping, length 22-70mm and 5.0mm, length 32-90 mm, Cobalt Chrome (CoCrMo) sterile 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-00596-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-06-18
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00596-1
  • 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
    The manufacturer is recalling dls 3.7mm and 5.0mm following customer complaints of breakages at the distal tip of the pin after successful healing and during planned implant removal of the whole construct. no complaints have been reported by australian customers.
  • 조치
    Customers are requested to quarantine all lots of the 3.7 mm and 5.0 mm Dynamic Locking Screws and contact a Depuy Synthes Trauma sales representative to organise the return of the affected devices. Depuy Synthes is also advising implanting surgeons of the appropriate follow up for patients implanted with the potentially affected Dynamic Locking Screw. For further details, please see http://www.tga.gov.au/safety/alerts-device-dynamic-130704.htm

Device

Dynamic Locking Screw Stardrive 3.7mm self tapping, length 22-70mm and 5.0mm, length 32-90 mm, Co...
  • 모델명 / 제조번호(시리얼번호)
    Dynamic Locking Screw Stardrive 3.7mm self tapping, length 22-70mm and 5.0mm, length 32-90 mm, Cobalt Chrome (CoCrMo) sterileDynamic Locking Screw Stardrive 3.7mm self tapping, length 22-70mm Cobalt-Chrome Alloy (CoCrMo) sterile, Part numbers: 09.213.22S, 09.213.070SDynamic Locking Screw Stardrive 5.0mm, self-tapping, length 32-90 mm, Cobalt Chrome (CoCrMo) sterilePart number: 09.223.032S, 09.223.090SAll lot numbers are affected
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd