Events

Retiro De Equipo (Recall) de Device Recall Gibralt Polyaxial 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 Exactech, 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
    67486
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1217-2014
  • Fecha de inicio del evento
    2014-01-06
  • Fecha de publicación del evento
    2014-03-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-08-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125540
  • 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
    Orthosis, spinal pedicle fixation - Product Code MNI
  • Causa
    The products have been identified to contain springs which have been manufactured with type-304 stainless steel rather than the specified titanium alloy.
  • Acción
    Exactech sent an "URGENT PRODUCT RECALL NOTICE" dated January 6, 2014, to all affected customers. The letter identified the product and action needed to taken by the customers. Customers were instructed to: 1) Immediately cease distribution. 2) Extend the information to accounts in possession of the product. 3) Verify if they have any of the subject Gibralt Screws from the specified lots. 4) Complete and fax back the attached form. 5) Return affected products. For further questions, please call ( 352) 327-4847.

Device

Device Recall Gibralt Polyaxial Screw
  • Modelo / Serial
    size 3.5mm x 10mm, Catalog #05-000-20-3510, Lot Number #35917001. size 3.5mm x 14mm, Catalog #05-000-20-3514, Lot Number 35917002 and 40023002. size 3.5mm x 20mm, Catalog #05-000-20-3520, Lot Number 35917003. size 3.5mm x 26mm, Catalog #05-000-20-3526, Lot Number 35917004. size 4.0mm x 14mm, Catalog #05-000-20-4014, Lot Number 35917005. size 4.0mm x 20mm, Catalog #05-000-20-4020, Lot Number 35917006. size 4.0mm x 26mm, Catalog #05-000-20-4026, Lot Number 35917007. 1/4 Shank, size 3.5mm x 26mm, Catalog #05-000-20-3526, Lot Number 35917008. 1/4 Shank, size 3.5mm x 30mm, Catalog #05-000-20-3530, Lot Number 35917009. 1/4 Shank, size 4.0mm x 26mm, Catalog #05-000-20-4026, Lot Number 35917010. 1/4 Shank, size 4.0mm x 30mm, Catalog #05-000-20-4030, Lot Number 35917011.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    USA Distribution including the states of FL, NY, OR, IL, PA, MO and NJ.
  • Descripción del producto
    Gibralt Spine System Polyaxial Screw || Intended to promote fusion of the cervical spine, and the thoracic spine, (C3-T3), the Gibralt Spinal System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C3-T3) spine.
  • Manufacturer
    Exactech, Inc.

Manufacturer

Exactech, Inc.
  • Dirección del fabricante
    Exactech, Inc., 2320 NW 66th Ct, Gainesville FL 32653-1630
  • Empresa matriz del fabricante (2017)
    Exactech Inc
  • Source
    USFDA