Events

Retiro De Equipo (Recall) de PAK NEEDLE BEVELED AND TROCAR TIPS

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 Sofamor Danek USA 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
    77049
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2047-2017
  • Fecha de inicio del evento
    2017-04-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-12-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154880
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Causa
    Product packaging may incorrectly include two bevel-tipped needles or two trocar-tipped needles instead of one diamond-tipped needle and one bevel-tipped needle.
  • Acción
    Medtronic sent an Urgent : Field Safety Corrective Action dated April 13, 2017, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Instructions to Customers: 1.) Please locate and remove the impacted product from normal storage locations. Do not use this product. 2.) Complete the enclosed Customer Confirmation Form and return via email to rs.sdmriskmgt@medtronic.com, or fax to 763-367-8134. 3.) As applicable, contact your Medtronic Sales Representative to coordinate the return and replacement of affected product. We regret any inconvenience this may cause. We are committed to patient safety and appreciate your prompt attention to this matter. If you have any questions regarding this communication, please contact our Post-Market Quality team at 901-399-3197. For further questions, please call (901) 344-1435.

Device

PAK NEEDLE BEVELED AND TROCAR TIPS
  • Modelo / Serial
    Lot number 0521148W, Exp. 10/21/2021
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution to the state of : OK and to the countries of : Italy, Germany, France , Belgium, Spain and Japan.
  • Descripción del producto
    Medtronic PAK NEEDLE BEVELED AND TROCAR TIPS, REF 8670009, QTY 1 EA, STERILE R, Rx only
  • Manufacturer
    Medtronic Sofamor Danek USA Inc

Manufacturer

Medtronic Sofamor Danek USA Inc
  • Dirección del fabricante
    Medtronic Sofamor Danek USA Inc, 1800 Pyramid Pl, Memphis TN 38132-1703
  • 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