Events

Synthes Kirschner Wire 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
    19552
  • 사례 시작날짜
    2015-12-10
  • 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 kirschner wire is made from co35ni35cr20mo10 (mp35n) which is cobalt based alloy containing 35% nickel. however, the label and technique guide incorrectly indicate that the devices are made of stainless steel., the product is shipped with an insert which references the potential risk of allergy/hypersensitivity reactions, but there is no specific information on the label or in the technique guide with regards to the percentage of nickel content in the devices., please note: - product shipped in "kits" in new zealand are not in packaging and therefore not labelled.
  • 조치
    Manufacturer to issue advice regarding use

Device

Synthes Kirschner Wire
  • 모델명 / 제조번호(시리얼번호)
    Model: Part No: 02.113.001, Affected: All Lot numbers
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH