Events

Retiro De Equipo (Recall) de Device Recall KyphX HVR Bone Cement

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Medtronic Spine LLC, formerly Kyphon Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    54384
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1624-2011
  • Fecha de inicio del evento
    2009-11-10
  • Fecha de publicación del evento
    2011-03-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-03-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88373
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Cement, bone, vertebroplasty - Product Code NDN
  • Causa
    Product may not reach proper viscosity (dough state) and inconsistency or lack of homogeneity during cement preparation and during delivery period.
  • Acción
    The firm, Medtronic Spine LLC, sent an "URGENT DEVICE RECALL NOTICE" dated November 9, 2009 to the customers. The notice described the product, problem and actions to be taken. The customers were instructed to return the affected lots to Medtronic Spine; to not use any of the affected product that they may have received (Medtronic will replace any affected product in their inventory), the customer should contact their Medtronic Spine sales representative or customer service at [866-959-7466 or for geography] for assistance with replacement product, and complete and return the URGENT DEVICE RECALL NOTICE: Action Required form to Medtronic Spine LLC via fax at (408) 543-6192 or mail to: Medtronic Spine LLC, Attn: Recall Coordinator, 1221 Crossman Avenue, Sunnyvale, CA 94089. If you have any questions about this notification, please do not hesitate to contact Sr. Director, Regulatory Affairs via email: pamela.n.segale@medtronic.com or phone at (408) 548-5235.

Device

Device Recall KyphX HVR Bone Cement
  • 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
    Orthopedic Devices
  • 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.
  • Manufacturer
    Medtronic Spine LLC, formerly Kyphon Inc

Manufacturer

Medtronic Spine LLC, formerly Kyphon Inc
  • Dirección del fabricante
    Medtronic Spine LLC, formerly Kyphon Inc, 1221 Crossman Ave, Sunnyvale CA 94089-1103
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • 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