Device Recall Syneture Sofsilk

  • 모델명 / 제조번호(시리얼번호)
    Lot Code Number:  D1C0052G D1C0054G D1C0323G D1C0372G D1C0384G D1C0442G D1C0477G D1C0482G D1C0690GX D1C0691GX D1C1009GX
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Denmark, France, Germany, Italy, Japan, Korea, and Singapore
  • 제품 설명
    Syneture Sofsilk 2/0 BLACK 5x18" V-20 D-TACH || non-absorbable silk sutures || GS62M || Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic, microsurgery and neurological surgery
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Covidien LP, 60 Middletown Ave, North Haven CT 06473-3908
  • 제조사 모회사 (2017)
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 5 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Lot Code Number:  D1C0383 D1C0414 D1C0416
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Denmark, France, Germany, Italy, Japan, Korea, and Singapore
  • 제품 설명
    Syneture Sofsilk 3/0 18" BLACK CV-25 DT || non-absorbable silk sutures || GS33M || Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic, microsurgery and neurological surgery
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot Code Number:  D1D0366X
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Denmark, France, Germany, Italy, Japan, Korea, and Singapore
  • 제품 설명
    Syneture Sofsilk 5/0 BLACK 5 X 18" CV-22 D*TACH || non-absorbable silk sutures || GS43M || Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic, microsurgery and neurological surgery
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot Code Number:  D1C0026 D1C0028
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Denmark, France, Germany, Italy, Japan, Korea, and Singapore
  • 제품 설명
    Syneture Sofsilk 4/0 18" BLACK CV-22 DT || non-absorbable silk sutures || GS44M || Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic, microsurgery and neurological surgery
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot Code Number:  D1C0078 D1C0202
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Denmark, France, Germany, Italy, Japan, Korea, and Singapore
  • 제품 설명
    Syneture Sofsilk 4/0 18" BLACK CV-22 DT || non-absorbable silk sutures || GS46M || Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic, microsurgery and neurological surgery
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot Code Number:  D1C0080G D1C0251G D1C0272G D1C0454G D1C0455G D1C0492G D1C0493G D1C0719GX D1C0893GX D1C0894GX D1C0930GX D1C0934GX D1C1004GX D1D0057GX D1D0306GX
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Denmark, France, Germany, Italy, Japan, Korea, and Singapore
  • 제품 설명
    Syneture Sofsilk 3/0 18" BLACK V-20 DT || non-absorbable braided nylon sutures || GS63M || Sofsilk is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic, microsurgery and neurological surgery
  • Manufacturer