Events

Synthes Insert for DHS/DCS Impactor No. 338.260, single 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
    18229
  • 사례 시작날짜
    2015-03-25
  • 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: Johnson & Johnson (NZ) Limited, 13a Gabador Place, Mt Wellington, AUCKLAND
  • 원인
    The dhs/dcs impactor is composed of two parts: a replaceable plastic tip which is the insert for dhs/dcs impactor (338.260), and a metallic shaft (338.280). no biocompatibility testing has ever been completed by the manufacturer, synthes, for the material (polyamide 6.6 with 20% carbon fibre reinforcement, tecamid 66 cf 20) for the insert and no evidence was found that it has been completed by other entities. potential for harm exists due to the potential for device breakage which may include surgical delay and adverse tissue reaction.
  • 조치
    Product to be exchanged

Device

Synthes Insert for DHS/DCS Impactor No. 338.260, single
  • 모델명 / 제조번호(시리얼번호)
    Model: Part Number: 338.260, Affected: All lots below 7985313
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH