Device Recall Syneture Surgilon

  • Modelo / Serial
    Lot Code Number:  D1C0200G D1C0662GX
  • 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 30" BLACK V-20 DT || non-absorbable braided nylon sutures || GS66M || 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

8 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Lot Code Number: D1C0077 D1C0274 D1A0463
  • 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 0 18" BLACK GS-21 DT || non-absorbable braided nylon sutures || CS10M || 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:  D1C0213
  • 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 BK 12X18" PRE-CUT WAX-RACE || non-absorbable braided nylon sutures || S194 || 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:  D1C0270
  • 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 0 BLACK 6X 18" PRE-CUT WAX/RACE || non-absorbable braided nylon sutures || S196 || 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:  D1D0288X
  • 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 Surgilon 5/0 Blk 5X18 T-37/CV-20 D-TACH || non-absorbable braided nylon sutures || Material 8886191022 || Surgilon is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic and neural tissue.
  • Manufacturer
  • Modelo / Serial
    Lot Code Number:  D1C0245X D1C0292X D1D0257X D1B0584X
  • 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 Surgilon 0 Blk 3X18 CE-10/C-16 || non-absorbable braided nylon sutures || Material 8886193662 || Surgilon is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic and neural tissue.
  • Manufacturer
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