Events

Retiro De Equipo (Recall) de Device Recall Allez Spine Cross Connectors

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 Allez Spine, 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
    49444
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0155-2009
  • Fecha de inicio del evento
    2008-08-21
  • Fecha de publicación del evento
    2008-10-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-01-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73337
  • 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
    Spinal Pedicle Fixation - Product Code NKB
  • Causa
    This action is being taken voluntarily as a result of a warning letter issued to aliez spine llc by the food & drug administration. the company decided it could better address the fda's concerns regarding current good manufacturing practice requirements of the quality system without any product in the market so it could focus all of its efforts on responding to the fda.
  • Acción
    Allez Spine issued a field notification beginning August 21, 2008 via FedEx to all its hospital users, distributors and field representatives informing them of their decision to recall the Allez Spine Laguna Pedicle Screw System, Allez Spine Del Mar Pedicle Screw System and the Allez Spine Cross Connectors as a result of a Warning Letter issued to AlIez Spine LLC by the Food & Drug Administration. The recall letter requested their customers to return their entire inventory of AlIez Spine manufactured products as soon as possible, gave instruction for product return and provided a contact person and telephone number for information regarding the recall.

Device

Device Recall Allez Spine Cross Connectors
  • Modelo / Serial
    All Serial Numbers
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution --- including states of AZ, CA, CO, GA, IL, NV, TN, TX, & UT.
  • Descripción del producto
    Allez Spine Cross Connectors; Catalog Number: LG-CC1001Cross Link, Small 30-37mm; LG-CC1002 Cross Link, Medium 37-50mm; LG-CC1003 || Cross Link, Lange 50-80mm; lT-T01003 Cross Link Torque Hex Driver, 2.5mm
  • Manufacturer
    Allez Spine, LLC

Manufacturer

Allez Spine, LLC
  • Dirección del fabricante
    Allez Spine, LLC, 2301 Dupont Dr Ste 510, Irvine CA 92612-7518
  • Empresa matriz del fabricante (2017)
    Allez Spine Llc
  • Source
    USFDA