Events

Retiro De Equipo (Recall) de Device Recall AOS Trochanteric Nail

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 Advanced Orthopaedic Solutions 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
    54538
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1191-2010
  • Fecha de inicio del evento
    2010-01-14
  • Fecha de publicación del evento
    2010-03-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88681
  • 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
    rod, fixation, intramedullary and accessories - Product Code HSB
  • Causa
    The recall was initiated after advanced orthopaedic solutions (aos) became aware of a manufacturing defect involving the short trochanteric nail, where one piece was found to be incorrectly bent. if this issue were to recur, surgery time could be extended, but only slightly as nail exchanges take place commonly in a surgery of this type.
  • Acción
    The recall was initiated with the firm forwarding a recall notice with attached customer response form on January 14, 2010 to the affected consignees. The recall notice informed the consignees of the reason for recall and gave them three steps to follow to inspect the affected Short Trochanteric Nail products. Consignees were provided with product return instruction for any incorrectly bent products found during their inspection. Customers with questions are instructed to contact the firm at (310) 533-9966.

Device

Device Recall AOS Trochanteric Nail
  • Modelo / Serial
    Lot Number: 09023.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide and Japan
  • Descripción del producto
    AOS Trochanteric Nail, 10mm x 20cm x 135¿, Product Part Number: 1042-200.
  • Manufacturer
    Advanced Orthopaedic Solutions Inc

Manufacturer

Advanced Orthopaedic Solutions Inc
  • Dirección del fabricante
    Advanced Orthopaedic Solutions Inc, 386 Beech Ave, Torrance CA 90501
  • Empresa matriz del fabricante (2017)
    Advanced Orthopedic Solutions Inc
  • Source
    USFDA