Events

AnspachR Single-use Cutting Burs and Irrigation Clips 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Synthes 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 날짜
    2011-10-04
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111004.html
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Field safety notice: synthes anspachr single-use cutting burs and irrigation clips medical device manufacturer, synthes, has issued a field safety notice concerning anspachr single-use cutting burs and irrigation clips used with anspachr electri and pneumatic high speed drill system. this removal is being conducted because anspachr has observed separation between the clear layers of the pouch during real time aging studies. as a result of the separation, it is possible to have a breach in the sterile barrier. this removal action is limited to product that is packaged in a tyvek pouch where the product is retained within a tube. products that are retained within a snap tray are not affected by this removal action. anspachr has not received any reports of incidents or adverse events related to this issue. according to the local supplier, affected products have been distributed in hk. if you are in possession of the affected products, please contact your supplier for necessary actions.

Device

AnspachR Single-use Cutting Burs and Irrigation Clips
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Synthes Anspach Single-use Cutting Burs and Irrigation Clips
  • Manufacturer
    Synthes

Manufacturer

Synthes