Device Recall Syneture TiCron

  • Modelo / Serial
    Lot Code Number:  D1C0983X
  • 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 Ti-Cron 2 BLUE 5X18" HGS-22 || non-absorbable polyester sutures || Material 8886337282 || Ti-Cron is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic and neurological procedures
  • 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

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Más información acerca de la data acá

  • Modelo / Serial
    Lot Code Number:  D1C0944X
  • 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 Ti-Cron 0 BLUE 6X18" PRE-CUT || non-absorbable polyester sutures || Material 8886300162 || Ti-Cron is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic and neurological procedures
  • Manufacturer
  • Modelo / Serial
    Lot Code Number:  D1C0553X D1C0554X
  • 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 Ti-Cron 0 5X18" BLUE T-19/GS-22 D-TACH || non-absorbable polyester sutures || Material 8886325962 || Ti-Cron is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic and neurological procedures
  • Manufacturer
  • Modelo / Serial
    Lot Code Number:  D1C0556X D1C0557X
  • 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 Ti-Cron 1 Blue 5x18 HGS-22 D-Tach || non-absorbable polyester sutures || Material 8886326062 || Ti-Cron is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic and neurological procedures
  • Manufacturer
  • Modelo / Serial
    Lot Code Number:  D1D0037X
  • 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 Ti-Cron 1 Blue 5x18 HGS-22 D-Tach || non-absorbable polyester sutures || Material 8886337272 || Ti-Cron is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic and neurological procedures
  • Manufacturer
  • Modelo / Serial
    Lot Code Number:  D1D0060X
  • 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 Ti-Cron 0 5X18" BLUE T-40/HGS-22 D-TACH, || non-absorbable polyester sutures || Material 8886337962 || Ti-Cron is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic and neurological procedures
  • Manufacturer