Events

Retiro De Equipo (Recall) de Device Recall Ceres SelfDrilling Variable Screw 4.0 x 12mm

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 Amendia, Inc.

¿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
    77986
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0316-2018
  • Fecha de inicio del evento
    2017-07-07
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158455
  • 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
    Intervertebral fusion device with integrated fixation, cervical - Product Code OVE
  • Causa
    Incorrect direct marking and color identification for the affected lot of ceres self-drilling variable screws. although the laser mark and color identify the screws as 12 mm in length, some screws in the lot measure 14 mm in length.
  • Acción
    The firm, Amendia, sent an "URGENT: MEDICAL DEVICE RECALL" letter to its Customers. The letter described the product, problem and actions to be taken. The customers were Instructed to examine inventory and quarantine affected products, notify customers if affected products were further distributed, coordinate the return of affected products back to Amendia by emailing: jconover@amendia.com or call 770-575-5236 or jwilliamson@amendia or call 770-575-5369, and to complete and return the Response Form. If there are questions, Amendia Customer Service can be contacted at 770-575-5224.

Device

Device Recall Ceres SelfDrilling Variable Screw 4.0 x 12mm
  • Modelo / Serial
    Model # 12-31-4012, Lot #133039
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Distributed to states of: AL, FL, GA, NY, TX, and VA.
  • Descripción del producto
    Ceres Self-Drilling Variable Screw 4.0 x 12mm || The Ceres screws are self-drilling variable screws that are intended to be used with the Ceres-C Stand-Alone Cervical System.
  • Manufacturer
    Amendia, Inc

Manufacturer

Amendia, Inc
  • Dirección del fabricante
    Amendia, Inc, 1755 W Oak Pkwy, Marietta GA 30062-2260
  • Empresa matriz del fabricante (2017)
    Spinal Elements
  • Source
    USFDA