Prosthesis System for Articular Replacements 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 N/A 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
  • 사례 ID
    R1709-459
  • 사례 연번
    2014DM-0011287
  • 날짜
    2017-09-29
  • 사례 국가
  • 사례 출처
    INVIMA
  • 사례 출처 URL
  • 비고 / 경고
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • 데이터 추가 비고

Device

  • 모델명 / 제조번호(시리얼번호)
    IMP74115, lot 012154004000
  • 제품 설명
    The prosthesis system for joint replacements and its associated instruments C2F is designed for the partial or total artificial replacement of the joints of the body and indicated for the treatment of joint complexes, osteoarthritis, joint instabilities. Allowing to restore mobility, correct joint deformities, joint reconstruction, with specific clinical indications according to articulation and reference. Prostheses for hip replacement of the prosthesis system for joint replacements and their associated instruments C2F, have other indications:? In case of pain due to the articulated joint destruction resulting from degenerative, inflammatory or post-traumatic pathology, or to the resulting effects after a trauma, or to the failure of previous operations. ? For first or secondintention surgery. ? Avascular necrosis. ? Traumatic arthritis ? Degenerative inflammatory disease of the joints including rheumatoid arthritis, arthritis secondary to a variety of diseases and abnormalities, and congenital dysplasia among other indications for use, prostheses for knee replacement of the prosthesis system for joint replacements and its associated instruments c2f®, for the treatment of:? Rheumatoid arthritis ? Post-traumatic arthritis, laosteoarthritis or degenerative arthritis. ? Failed osteotomies? Advanced articular destruction resulting from degenerative, inflammatory opost-traumatic pathology? Surgery of first intention, in the primary gonarthrosis associated to: important axial deviation, important laxity or important rigidity. ? Revision surgery of knee prostheses that have been found, in particular, in the case of a second recurrence of axial deviation, abnormal laxity or severe rigidity.
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    NIDFSINVIMA