Device Recall Syneture Sofsilk

  • Modelo / Serial
    Lot Code Number:  D1C0080G D1C0251G D1C0272G D1C0454G D1C0455G D1C0492G D1C0493G D1C0719GX D1C0893GX D1C0894GX D1C0930GX D1C0934GX D1C1004GX D1D0057GX D1D0306GX
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Denmark, France, Germany, Italy, Japan, Korea, and Singapore
  • Descripción del producto
    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
  • 1 Event

Fabricante

  • Dirección del fabricante
    Covidien LP, 60 Middletown Ave, North Haven CT 06473-3908
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “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

5 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Lot Code Number:  D1C0383 D1C0414 D1C0416
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Denmark, France, Germany, Italy, Japan, Korea, and Singapore
  • Descripción del producto
    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
  • Modelo / Serial
    Lot Code Number:  D1D0366X
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Denmark, France, Germany, Italy, Japan, Korea, and Singapore
  • Descripción del producto
    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
  • Modelo / Serial
    Lot Code Number:  D1C0026 D1C0028
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Denmark, France, Germany, Italy, Japan, Korea, and Singapore
  • Descripción del producto
    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
  • Modelo / Serial
    Lot Code Number:  D1C0078 D1C0202
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Denmark, France, Germany, Italy, Japan, Korea, and Singapore
  • Descripción del producto
    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
  • Modelo / Serial
    Lot Code Number:  D1C0052G D1C0054G D1C0323G D1C0372G D1C0384G D1C0442G D1C0477G D1C0482G D1C0690GX D1C0691GX D1C1009GX
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Denmark, France, Germany, Italy, Japan, Korea, and Singapore
  • Descripción del producto
    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