CMF MatrixMIDFACE, MANDIBLE and ORTHOGNATHIC Screws 에 대한 현장 안전성 서한

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI)에 따르면, 해당 현장 안전성 서한 는 Slovenia 에서 Synthes GmbH 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Field Safety Notice
  • 날짜
    2017-02-21
  • 사례 국가
  • 사례 출처
    AMPMDRS
  • 비고 / 경고
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • 데이터 추가 비고
  • 원인
    Please note that these products were originally recalled in 2013. unfortunately, due to an error, they were re-distributed. we apologize for this inconvenience. synthes is initiating a voluntary recall of the below mentioned lots of the cmf matriledface, mandible and orthognathic due to the possibility that clips on the screws may be incorrectly etched with the wrong length. each screw is packaged in a “clip” that has a laser etch corresponding to the length of the screw. it has been reported that the etch on the clip does not correspond to the length of the screw. there have been instances in which the screw was longer than the specified etch, as well as the screw being shorter than the specified etch. please note: there has not been any adverse event to patient reported with use of these screws, in all cases of complaints received, there was no patient mm it is not likely that the presence of a screw that is packaged in the incorrect clip holder will result in a serious adverse event. there is a remote probability that a medically reversible or transient adverse health event will result due to a screw being packaged in the incorrect clip holder.

Device

  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer

Manufacturer