Events

Synthes Craniomaxillofacial (CMF) Distraction System, BC Distraction Bodies 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
    16596
  • 사례 시작날짜
    2014-05-14
  • 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
    The ab and bc distractor bodies used in the craniomaxillofacial distraction system may reverse post-operatively., in the presence of inadequate distraction or reversal of a previously achieved distraction distance, the patient may need to undergo prolonged distraction therapy. in some instances, revision surgery may be needed to replace the device., reversing occurs when the distractor screw is turned in the opposite direction to cause the assembly to lose distraction distance.
  • 조치
    Product to be returned to supplier

Device

Synthes Craniomaxillofacial (CMF) Distraction System, BC Distraction Bodies
  • 모델명 / 제조번호(시리얼번호)
    Model: Models: 04.315.064 and 04.315.066, Affected: Lots: 6342004, 7351857 and 6651388, 6913921, 718588 respectivly
  • 의료기기 분류등급
    Dental Devices
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH