Midas Rex Legend Dissecting Tool


  • 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

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Más información acerca de la data acá

  • Modelo / Serial
    Lot numbers: 0000710253, 0000710254, 0000710256, 0000710257, 0000710258, 0000710266, 0000710267, 0000710271, 0000710272, 0000710274, 0000710275, 0000710276, 0000710277, 0000710278, 0000710279, 0000710280, 0000710281, and 0000710288
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    Medtronic Midas Rex Legend tapered dissecting tool, Model F2/8TA23 || Medtronic Powered Surgical Solutions, Forth Worth, TX || Intended for use in Spinal, Cranial, Orthopedic, General Surgical and Plastic Surgery applications for transection, osteotomy, graft harvesting, bone shaping, laminectomy, entry hole, suture hole, and midface advancement.
  • Manufacturer