Events

Retiro De Equipo (Recall) de Device Recall Ossur Lil Angel Vest

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 H / F.

¿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
    73382
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1515-2016
  • Fecha de inicio del evento
    2016-03-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-08-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144635
  • 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
    Component, traction, non-invasive - Product Code KQZ
  • Causa
    There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.
  • Acción
    Customer notification letter were sent on 03/14/16 via traceable method. The notification asked customers to examine their inventory, quarantine product subject to the recall and contact customer service for a return authorization to return the product to Ossur. Customers were asked to take the following actions: 1. Pass the notice to those who need to be aware within the organization or to any organization where the potentially affected devices have been transferred. 2. Maintain awareness on the notice for an appropriate period. 3. If have further distributed this product identify the customers and notify them at once of this product alert. It is recommended that a copy of the notice is included. 4. If any customers are currently wearing a product it is recommended a detailed inspection of the product vest structurebe conducted to ensure there is no visible cracks on the vest.

Device

Device Recall Ossur Lil Angel Vest
  • Modelo / Serial
    P/N: 545150S units from 2008 to current
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Distribution US Nationwide and Hong Kong
  • Descripción del producto
    Ossur Lil Angel Vest P3 Sorbatex. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.
  • Manufacturer
    Ossur H / F

Manufacturer

Ossur H / F
  • Dirección del fabricante
    Ossur H / F, Grjothals 5, Reykjavik Iceland
  • Empresa matriz del fabricante (2017)
    Össur hf
  • Source
    USFDA