Events

Synthes SynFix-LR Implant Holder 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Synthes GmbH 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
    16641
  • 사례 시작날짜
    2014-05-06
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Synthes New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, Auckland 1060
  • 원인
    Complaints have been received which describe the synfix-lr implant holder breaking at the interface between the implant and holder. if an un-retrieved device fragment remains threaded into the plate, it will not be possible to properly attach the synfix-lr aiming device to the implant (plate). proper attachment of the aiming device to the plate is required for accurate insertion of the four synfix-lr screws into the synfix-lr implant (plate) and vertebral bodies. if the tip of the holder should break, the potential exists for an un-retrieved device fragment (urdf) to be left in the synfix-lr implant.
  • 조치
    Instructions for use to be updated

Device

Synthes SynFix-LR Implant Holder
  • 모델명 / 제조번호(시리얼번호)
    Model: Part Number 03.802.039, Affected: All lots
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH