Events

Retiro De Equipo (Recall) de Device Recall Aliquot Delivery Kit (Syringe and Plunger)

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 Orthovita, Inc., dBA Stryker Orthobiologics..

¿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
    72054
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2772-2015
  • Fecha de inicio del evento
    2015-08-20
  • Fecha de publicación del evento
    2015-09-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139677
  • 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
    Dispenser, cement - Product Code KIH
  • Causa
    Two isolated instances of holes in the outer header bag component of the double barrier sterile packaging configuration.
  • Acción
    Stryker Sent an Urgent Product Recall letter dated August 20, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken by the Customer/User: Our records indicate that you have received the above referenced instruments. It is Stryker Orthobiologics responsibility as the manufacturer to ensure that customers who may have received these affected instruments also receive this important communication. Please assist us in meeting our regulatory obligation by faxing back the attached Product Recall Acknowledgment Form as soon as possible to 215-253-5020. We regret any inconvenience this action may cause you and if you have any questions, please contact Stryker Orthobiologics at 610-640-1775 x 5299.

Device

Device Recall Aliquot Delivery Kit (Syringe and Plunger)
  • Modelo / Serial
    All lots, Model Number of device: 2090-0501, 2090-0502, 2090-0504, 2090-0505
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - Nationwide Distribution and to the countries of : Australia, Belgium, Denmark, France, Germany, Italy, Malta, Netherlands, South Africa, Spain, Sweden, Switzerland, Turkey and United Kingdom.
  • Descripción del producto
    Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakened or diminished bone
  • Manufacturer
    Orthovita, Inc., dBA Stryker Orthobiologics.

Manufacturer

Orthovita, Inc., dBA Stryker Orthobiologics.
  • Dirección del fabricante
    Orthovita, Inc., dBA Stryker Orthobiologics., 45 Great Valley Pkwy, Malvern PA 19355-1302
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA