Events

Retiro De Equipo (Recall) de Device Recall Uniflex Ti Buttress Thread Screw

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 EBI, L.P..

¿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
    51725
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-2116-2009
  • Fecha de inicio del evento
    2009-03-27
  • Fecha de publicación del evento
    2009-09-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-09-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81095
  • 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
    Intramedullary Fixation Rod and Accessories - Product Code HSB
  • Causa
    Certain lots of raw material contain inclusions that could potentially reduce the strength of some devices.
  • Acción
    Letters to Biomet/EBI reps were sent on March 29, 2009 by US mail to alert them of the product recall and the affected parts that may be in their possession. They were also asked to notify each customer and locate all affected inventory. All letters advised of the recall and the specific lot numbers involved. A letter was sent to the hospital and physician that received affected parts and asked that implanting physicians make any medical decisions.

Device

Device Recall Uniflex Ti Buttress Thread Screw
  • Modelo / Serial
    Catalog number: 33-345532; Lot number 598990
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution -- USA and Spain.
  • Descripción del producto
    Uniflex Ti Buttress Thread Screw; || TI Screw Buttress Thread || Trauma Fixation Systems, Rx only || Biomet, 100 Interpace Parkway, Parsippany, NJ 07054 || Intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred.
  • Manufacturer
    EBI, L.P.

Manufacturer

EBI, L.P.
  • Dirección del fabricante
    EBI, L.P., 100 Interpace Pkwy, Parsippany NJ 07054-1149
  • Source
    USFDA