Events

Retiro De Equipo (Recall) de Device Recall Orthopedic Alliance Spine System (alias "Blue & Gold")

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 Orthopedic Alliance LLC.

¿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
    64584
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1156-2013
  • Fecha de inicio del evento
    2013-03-07
  • Fecha de publicación del evento
    2013-04-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-03-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116550
  • 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
    Orthopedic alliance is recalling blue & gold implants and instruments because the blue & gold system is not supported by adequate testing and documentation to demonstrate that it meets performance or safety standards. these inadequacies might result in product peformance failures that could cause patient harm due to implant breakage, loosening, or inadequate sterilization.
  • Acción
    A recall letter dated March 7, 2013 was sent to one customer who purchased the Blue & Gold Implants and instruments. The letter informed the customer that the Blue & Gold system is not supported by adequate testing and documentation to demonstrate that it meets performance or safety standards. These inadequacies might result in product performance failures that could cause patient harm due to implant breakage, loosening, or inadequate sterilization. Customer is informed of the actions to be taken. Customer is instructed to complete the customer response form and return it by FAX to (858) 764-9739.

Device

Device Recall Orthopedic Alliance Spine System (alias "Blue & Gold")
  • Modelo / Serial
    All lots are being recalled.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Distributed in Texas.
  • Descripción del producto
    Orthopedic Alliance Spine System (alias "Blue & Gold") || Part Numbers: || BGC3010 Screw Cap || BGR0040 Straight Rod 5.5 x 40mm || BGR0050 Straight Rod 5.5 x 50mm || BGR0060 Straight Rod 5.5 x 60mm || BGR0070 Straight Rod 5.5 x 70mm || BGR0080 Straight Rod 5.5 x 80mm || BGR0090 Straight Rod 5.5 x 90mm || BGR0100 Straight Rod 5.5 x 100mm || BGR0110 Straight Rod 5.5 x 110mm || BGR0120 Straight Rod 5.5 x 120mm || BGR0130 Straight Rod 5.5 x 130mm || BGR0140 Straight Rod 5.5 x 140mm || BGR0150 Straight Rod 5.5 x 150mm || BGR0200 Straight Rod 5.5 x 200mm || BGR0300 Straight Rod 5.5 x 300mm || BGR0400 Straight Rod 5.5 x 400mm || BGR0500 Straight Rod 5.5 x 500mm || BGS5535 5.5 x 35mm Polyaxial Screw || BGS5540 5.5 x 40mm Polyaxial Screw || BGS5545 5.5 x 45mm Polyaxial Screw || BGS6035 6.0 x 35mm Polyaxial Screw || BGS6040 6.0 x 40mm Polyaxial Screw || BGS6045 6.0 x 45mm Polyaxial Screw || BGS6050 6.0 x 50mm Polyaxial Screw || BGS6535 6.5 x 35mm Polyaxial Screw || BGS6540 6.5 x 40mm Polyaxial Screw || BGS6545 6.5 x 45mm Polyaxial Screw || BGS6550 6.5 x 50mm Polyaxial Screw || BGS7035 7.0 x 35mm Polyaxial Screw || BGS7040 7.0 x 40mm Polyaxial Screw || BGS7045 7.0 x 45mm Polyaxial Screw || BGS7050 7.0 x 50mm Polyaxial Screw || BGS7055 7.0 x 55mm Polyaxial Screw || BGS7535 7.5 x 35mm Polyaxial Screw || BGS7540 7.5 x 40mm Polyaxial Screw || BGS7545 7.5 x 45mm Polyaxial Screw || A pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients.
  • Manufacturer
    Orthopedic Alliance LLC

Manufacturer

Orthopedic Alliance LLC
  • Dirección del fabricante
    Orthopedic Alliance LLC, 26157 Jefferson Ave, Murrieta CA 92562-9561
  • Source
    USFDA