Events

Retiro De Equipo (Recall) de Device Recall OSTEOMED PrimaLOK FF Threaded Implant Driver Shaft

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 Osteomed, Lp.

¿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
    59213
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0008-2012
  • Fecha de inicio del evento
    2011-06-07
  • Fecha de publicación del evento
    2011-10-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-12-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101895
  • 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
    System, facet screw spinal device - Product Code MRW
  • Causa
    Two of the implant driver assembly tips were reported to break during surgery.
  • Acción
    OsteoMed LP sent an Urgent --Product Recall letter dated June 7, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory immediately for affected inventory and promptly return any affected inventory to: OsteoMed LP Attan: Rebecca Ellis 3885 Arapaho Road Addison, Texas 75001 If the customer further distributed any of the affected product customers were instructed to immediately contact their accounts and advise them of the recall situation and have them return any devices they may have to OsteoMed at the above address. Customers were asked to complete and return the enclosed response immediately in the enclosed, postage paid envelope even if they do not have the device. For any questions please call (800) 456-7779.

Device

Device Recall OSTEOMED PrimaLOK FF Threaded Implant Driver Shaft
  • Modelo / Serial
    Part Number 800-1212 lot # 1038452.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution including PA, TX, CA, IL IA, FL, CT, and MO
  • Descripción del producto
    OSTEOMED SPINE Facet Fixation System PrimaLOK FF Threaded Implant Driver Shaft OsteoMed L.P. 3885 Arapaho Road, Addison, Texas 75001
  • Manufacturer
    Osteomed, Lp

Manufacturer

Osteomed, Lp
  • Dirección del fabricante
    Osteomed, Lp, 3885 Arapaho Rd, Addison TX 75001
  • Empresa matriz del fabricante (2017)
    Colson Associates Inc.
  • Source
    USFDA