Events

Retiro De Equipo (Recall) de Device Recall Stryker

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 Stryker Howmedica Osteonics Corp..

¿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
    65646
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1846-2013
  • Fecha de inicio del evento
    2013-05-21
  • Fecha de publicación del evento
    2013-07-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-10-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119805
  • 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
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • Causa
    Stryker osteosynthesis has become aware that left gamma3 nails are marked as right nails.
  • Acción
    Stryker sent notification letters and product accountability forms dated May 21, 2013. via Fed Ex with return receipt to all branches/agencies and on May 22, 2013, via Fed Ex with return receipt to all hospital risk management, chief of orthoapedics, and surgeons. Our records indicate that you may have received and/or used the above referenced product(s). It is Stryker's¿¿ responsibility as the manufacturer to ensure that customers who may have received and/or used these affected products also receive this important communication. Please contact your Stryker¿¿ Sales Representative to arrange for return of the product if you have any of the above listed items. Please assist us in meeting our regulatory obligation by faxing back the attached Product Recall Acknowledgment Form as soon as possible to 855- 251-3635. Please note that your signature on the following form only confirms that you received this notification and does not obligate you to take any additional action beyond what is called for in this notification letter. We regret any inconvenience this action may cause you and if you have any questions, please call (201) 972-2100.

Device

Device Recall Stryker
  • Modelo / Serial
    Catalog Number- 33250400S Catalog Number 33250360S
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Distribution including the states of IL, KY and TN.
  • Descripción del producto
    GAMMA3 System Long Nail Kit, R2.0, Ti, Left || Distributed in USA by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA || A single use device intended for the temporary fixation, correction of stabilization of the right femur. The kit consists of intramedullary nail and set screw. The kit is used in combination with lag screw and (distal) locking screws and end cap as well.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Dirección del fabricante
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2002
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA