Events

Retiro De Equipo (Recall) de Device Recall Vitagel

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
    70609
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1353-2015
  • Fecha de inicio del evento
    2015-02-26
  • Fecha de publicación del evento
    2015-03-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-07-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134154
  • 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
    Implant, dermal, for aesthetic use - Product Code LMH
  • Causa
    Several shipments of vitagel product (a surgical hemostat) required to be stored at 2 -8 degrees celsius (c) were not delivered to customers within the validated delivery time.
  • Acción
    Orthovita, Inc., dBA Stryker Orthobiiologics made phone notifications in February 2015 to all affected customers. Customers were told that the Vitagel they ordered on x date has an internal procedural mandate that says they must deliver in 35 hours and it has now passed that window. As a precaution until we can confirm that Vitagel delivered after shipping for longer is safe for use we are asking that they quarantine the order in question in the event the delivery occurs. For questions regarding this recall call 610-640-1775.

Device

Device Recall Vitagel
  • Modelo / Serial
    Product Numbers: 2113-0000, 2113-0202 , 2113-0205; Lot Numbers: A1407061, A1406053, A1410055, A1501033, A1407037, A1412010, A1412076; Expiry Dates: 02/28/2017, 08/31/2016, 03/31/2017, 10/31/2016, 10/31/2016, 01/31/2017, 09/30/2016
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution including NY PA WV MI IL MA TX AR KS FL WI CA MO LA VA IA OH and NC.
  • Descripción del producto
    Vitagel; indicated in surgical procedures (other than in neurosurgical and ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
  • 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