Events

Retiro De Equipo (Recall) de Device Recall 45 Angle Driver

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 Greatbatch Medical.

¿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
    64129
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0751-2013
  • Fecha de inicio del evento
    2013-01-16
  • Fecha de publicación del evento
    2013-01-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-09-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115397
  • 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
    Greatbatch medical has initiated a global voluntary recall and market withdrawal of its entire small angled driver 45¿ product line. greatbatch has received reports of noisy and / or rough operation when using these small angled drivers.
  • Acción
    Greatbatch sent an "URGENT MEDICAL DEVICE RECALL" letter dated January 15, 2012 to all affected customers. The letter described the Reason For Recall, Risk to Health, and Instructions to Customers. Advised consignees to examine their inventory and quarantine the product in question. If they have further distributed the product to notify their customers and to complete and return the "Recall Response Form". Contact the firm at 1-763-951-8235 for questions relating to this notice.

Device

Device Recall 45 Angle Driver
  • Modelo / Serial
    All lots
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA including the states of CA, IN, KS, MA, NJ, PA, TN, and TX, and the countries of AUSTRALIA, BRAZIL, CANADA, DENMARK, FRANCE, GERMANY, ITALY, JAPAN, PORTUGAL, and SWITZERLAND.
  • Descripción del producto
    45¿ Angle Driver / Z-H, Greatbatch Medical 10 000 Wahrie Drive, Clarance, NY 14031. || Model #: || P2661, P2662, T3635, T5586,T6031, T6164,T10161, T12628,T14879, T16422,T2487,T2713,T116057, T13635, MPU260045AO01, MPU260045ZH01. || The Driver is intended to act as an interface between the cutting tool and a motorized driving system (i.e. surgical drill).
  • Manufacturer
    Greatbatch Medical

Manufacturer

Greatbatch Medical
  • Dirección del fabricante
    Greatbatch Medical, 2300 Berkshire Ln N, Minneapolis MN 55441-4575
  • Empresa matriz del fabricante (2017)
    Integer Holdings Corporation
  • Source
    USFDA