Medtronic Sofamor Danek Usa, Inc - Dallas Distribution

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Description

  • Dirección del fabricante
    Medtronic Sofamor Danek Usa, Inc - Dallas Distribution, 4620 N Beach St, Haltom City TX 76137-3219
  • 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
  • 3 Event

3 dispositivos en la base de datos

  • Modelo / Serial
    Catalog Number: 16TA24, Lot Number: 0006936810
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed in the states of California, New York, and Texas and the country of Belgium.
  • Descripción del producto
    Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used by surgeons to drill holes.
  • Modelo / Serial
    Product Catalog Number: 10BA40D, Lot Number: H5237248
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed in France, Ireland, Netherlands, Portugal, Switzerland, and United Kingdom.
  • Descripción del producto
    Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. || Intended for use in neurosurgery.
  • Modelo / Serial
    All Serial Numbers.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-Including the states of AL, AR, AZ, CA, CT, FL, GA, IA, ID, IL, IN, MA, MD, NC, NH, NY, SC, TN, TX, and UT.
  • Descripción del producto
    Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number: ES300-R; Saw Saggital, Finger Catalog Number: ES310; Saw Saggital, Finger Refurbished Catalog Number: ES310-R; Used to dissect bone in surgical applications.

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  • Dirección del fabricante
    Medtronic Sofamor Danek Usa, Inc - Dallas Distribution, 4620 N Beach St, Fort Worth TX 76137-3219
  • 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