Events

Retiro De Equipo (Recall) de 3" Ceramic Tip Pin

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 Ossur.

¿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
    50111
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0595-2009
  • Fecha de publicación del evento
    2009-01-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-04-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74752
  • 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
    Fixation Accessory - Product Code LYT
  • Causa
    Ossur has initiated this voluntary recall as a precautionary measure because the firm is unable to guarantee the sterility of the affected products.
  • Acción
    Ossur initiated contact with the customers to locate the pins on Sept. 26, 2008 with the Product Manager for this device contacting each consignee by phone. The customers were informed the recall was initiated because the firm was unable to guarantee the sterility of the affected products. Customers were asked to check their inventory for the affected parts. If products were located, they were informed that an Ossur customer service representative will be emailing you with return information any they are to return these pins to the firm as soon as possible. They were also told Ossur does not currently have replacement product available, but they will contact them immediately when they are available. If the products were not located, they were asked to determine where these pins are currently located, if they have been applied to a patient? If so, are they able to track down that patient and bring them in for an evaluation?

Device

3" Ceramic Tip Pin
  • Modelo / Serial
    Lot Number: 08060408
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution --- including states of FL, KS, MI, MO, NY, & WA.
  • Descripción del producto
    Ossur 3" Ceramic Tip Pin, 4 pack, Model Number: 517DS
  • Manufacturer
    Ossur

Manufacturer

Ossur
  • Dirección del fabricante
    Ossur, Grjothals 5, Reykjavik Ireland
  • Source
    USFDA