Events

Retiro De Equipo (Recall) de Device Recall POWEREASE(TM) Instruments Set Screw Breakoff Instrument

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
    70032
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0952-2015
  • Fecha de inicio del evento
    2014-12-03
  • Fecha de publicación del evento
    2015-01-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-09-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132161
  • 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
    Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment - Product Code HWE
  • Causa
    The retaining tabs component of the set screw retaining drive may be oversized, which will not allow proper mating between the set screw retaining drive and the set screw.
  • Acción
    Medtronic sent an Urgent - Voluntary Market Removal letter dated December 3, 2014, 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 remove the product from normal storage locations. Do not use this product. 2.) As applicable, contact your Medtronic Sales Representative to coordinate the return of affected product. Alternatively, you may call Medtronic's Global Quality Department at (800) 876 -3133, extension 3197 for assistance If you need assistance or have any related questions or concerns, please do not hesitate to contact your Medtronic Sales Representative or the Global Quality Department at (800) 876 - 3133, extension 3197. We sincerely apologize for this inconvenience, but this action is necessary to assure that our high standard of quality is maintained.

Device

Device Recall POWEREASE(TM) Instruments Set Screw Breakoff Instrument
  • Modelo / Serial
    Lot # - CA14C107
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution to the states of : CA, KS, KY, NC, TX, WA, MI, OH, IA, PA, OR, MS, FL, NY, GA and AR.
  • Descripción del producto
    POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic Sofamor Danek, USA, Inc. Spinal surgical instrumrent.
  • Manufacturer
    Medtronic Sofamor Danek USA Inc

Manufacturer

Medtronic Sofamor Danek USA Inc
  • Dirección del fabricante
    Medtronic Sofamor Danek USA Inc, 1800 Pyramid Place, Memphis TN 38132
  • 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