Events

Retiro De Equipo (Recall) de Device Recall Stryker Orthobiologics Aliquot Plunger, 8", Part Number 21100502

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
    63204
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1397-2013
  • Fecha de inicio del evento
    2012-11-10
  • Fecha de publicación del evento
    2013-05-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-10-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115065
  • 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
    Injector, vertebroplasty (does not contain cement) - Product Code OAR
  • Causa
    There have been a few reported cases of the catheter breaking when removing the aliquot catheter from the needle during vertebroplasty procedures. this has been attributed to bending of the catheter during the retraction from the needle. it was determined to be use errors. the correction is limited to a revision of the directions for use.
  • Acción
    Stryker sent an Urgent Medical Device Correction letter dated November 10, 2012 to all affected customers. The letter identified the affected product, problem issue, potential hazards and actions to be taken. Customers were instructed to immediately review this notification and the attached IFU. Customers were asked to complete and sign the enclosed Business Reply Form and fax a copy to 1-484-323-8803. For questions contact Stryker Orthobiologics.

Device

Device Recall Stryker Orthobiologics Aliquot Plunger, 8", Part Number 21100502
  • Modelo / Serial
    Manufacturer Part Number 2110-0502, Lot Number E909008R
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    USA Nationwide Distribution in the states of AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MD, ME, MI, MO, NC, ND, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI.
  • Descripción del producto
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 8", Part Number 2110-0502 || Product Usage: || 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