Medtronic Spine LLC, formerly Kyphon Inc

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Description

  • Dirección del fabricante
    Medtronic Spine LLC, formerly Kyphon Inc, 1221 Crossman Ave, Sunnyvale CA 94089-1103
  • 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
    Lot Numbers: 0000776598, 0000790377, 0000790380, 0000794905, 0000794997, 0000794998, 0000794999, 0000795000, 0000802774, 0000802775, 0000819410, 0000825149, 0000828632, 0000828633, 0000841918, 0000841919, 0000842869, 0000842871, 0000848666, 0000848670, 0000858673, 0000892106, 000089859, 0000911555, 0000922990, 0000925894, 0000930458, 0000931993, 0000945996, 0000952887, 0000958800, 00009666732, 0000966734, 0000972324, 0000972325, 0000975787, 0000982884, 0000994176, 0001008470, 0001008472, 0001008598, 0001033988, 0001034877, 0001045184, 0001045187, 0001050788, 0001050789, 0001056101, 0001056102, 0001060659, 0001060662, 0001067884, 0001067886, 0001081545, 0001104034, 00841918, 88930458, J6092716, J6100426, J6101208, J6101808, J6103009, J6110310, J6110906, J6112008, J6112712, J6120108, J6121203, J6121902, J6121903, J6121904, J6121905, J6121906, J7010201, J7011107, J7011907, J7012506, J7020624, J7021509, J7022202, J7022702, J7030605, J7031401, J7031506, J7032310, J7032702, J7040213, J7041010, J7041301, J7042109, J7050101, J7050405, J7051107, J7051801, J7052511, J7060205, J7061130, J7062109, J7062708, J7070210, J7070706, J7071602, J7071906, J7072702, J7080702, J7081815, J7081816, J7082816, J7090620, J7091106, J7091208, J7091206, J7100606, J7101704, J7101705, J7110523, J7111216, J7111608, J7112823, J7120314, J7122101, J8010201, J8010402, J8010918, J8010718, J8041401, J8041705, J8042401, J8051203, J8051204, J8052915, J8052916, J8060205, J8060410, J8061208, J8010919, J8012214, J8013005, J8020117, J8020722, J8021910, J8030517, J8030518, J8031202, J8032601, J8040717, J8061209
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    USA including states of: AL, AR, AZ, CA, CO, DC, FL, GA, IA, IN, KY, MA, MD, MO, MT, NC, NM, NV, NY, OH, PA, SC, TN, TX, UT, VA, WI, and WV; and countries including: Argentina, Austria, Belgium, Brazil, Canada, Chile, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Ivory Coast, Jordan, Kuwait, Lebanon, Luxembourg, Lybia, Malaysia, Malta, Mexico, Morocco, Netherlands, New Caledonia, Norway, Panama, Philippines, Poland, Portugal, Puerto Rico, Reunion, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Turkey, United Arab Emirates, United Kingdom and Vietnam.
  • Descripción del producto
    Medtronic brand KyphX HV-R Bone Cement with Kyphon mixer, a polymethyl bone cement kit consisting of a quantity of powder (20 g) and a volume of liquid (10 ml/9 g) mixed in a Kyphon mixer for up to two minutes. Model Number: CO1B; Manufactured by Elmdown LTD, London, England, for Medtronic Spine LLC, Sunnyvale, CA. || Product is a medical device used during balloon kyphoplasty to cement structures in fractured vertebral bodies.
  • Modelo / Serial
    Lot Numbers: EL15106, EL15406, EL15706, EL16006, EL16406, EL16506, EL16806, EL17006, EL17307, EL17507, EL17607, EL17707, EL17807, EL18007, EL18307, EL18407, EL18707, EL18907, EL19207, EL19507, EL19807, EL20007, EL20107, EL20307, EL20407, EL20507, EL20607, EL20808, EL20908, EL21008, EL21208, EL21308, EL21608, EL21708, EL21908, EL22008, EL22108, EL22308, EL22908, EL23008, EL23508, EL23608, EL23708, EL24008, 24108, EL24208, EL24408, EL24508, EL24608, EL25008, EL25108, EL25408, EL25508, EL26409, EL26509
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    USA including states of: AL, AR, AZ, CA, CO, DC, FL, GA, IA, IN, KY, MA, MD, MO, MT, NC, NM, NV, NY, OH, PA, SC, TN, TX, UT, VA, WI, and WV; and countries including: Argentina, Austria, Belgium, Brazil, Canada, Chile, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Ivory Coast, Jordan, Kuwait, Lebanon, Luxembourg, Lybia, Malaysia, Malta, Mexico, Morocco, Netherlands, New Caledonia, Norway, Panama, Philippines, Poland, Portugal, Puerto Rico, Reunion, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Turkey, United Arab Emirates, United Kingdom and Vietnam.
  • Descripción del producto
    Medtronic brand KyphX HV-R Bone Cement, a polymethyl bone cement consisting of a quantity of powder (20 g) and a volume of liquid (10 ml/9 g) mixed in a Kyphon mixer for up to two minutes. Model Number: CO1A; Manufactured by Elmdown LTD, London, England, for Medtronic Spine LLC, Sunnyvale, CA. || Product is a medical device used during balloon kyphoplasty to cement structures in fractured vertebral bodies.
  • Modelo / Serial
    Catalog number K09A, Lot number 50000231, UPN 00858196001161.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Product was distributed to two hospitals in OH and FL.
  • Descripción del producto
    KyphX Xpander Inflatable Bone Tamp, size 15/3, Catalog Number K09A, Manufactured by Kyphon Sarl, Switzerland. For use in spinal surgery.