Events

Retiro De Equipo (Recall) de Orthofix Pedicle Screw Spinal System

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 Orthofix 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
    57211
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1608-2011
  • Fecha de inicio del evento
    2010-10-22
  • Fecha de publicación del evento
    2011-03-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-04-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95603
  • 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, for degenerative disc disease - Product Code NKB
  • Causa
    There is a possibility that certain anti-splay caps may not mate properly during assembly of the construct to the screw body with multi-axial reduction screw assemblies.
  • Acción
    The firm, Orthofix, sent an "URGENT: PRODUCT RECALL" letter dated October 22, 2010 to all customers. The letter describes the product, problem and the action to be taken by the customers. The customers were instructed to: 1) identify and remove the affected product 2) complete the enclosed Tracking and Verification Form via fax to: Orthofix Inc. at 214-937-2764, and 3) contact their Account Services Representative at 1-888-298-5700 and obtain a return authorization number to return product to Orthofix, Inc. The letter also states that Orthofix Inc., will provide replacement Anti-Splay Caps via priority delivery. If you have any questions regarding the removal and return of this product to Orthofix Inc., please contact your Account Service Representative at 1-888-298-5700. Should you have any other questions or concerns, please contact the Director of Regulatory Affairs at 214-937-2061 or by email: DarlaChew@Orthofix.com.

Device

Orthofix Pedicle Screw Spinal System
  • Modelo / Serial
    Part #68-0111, Lot #16518-LC18.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide distribution: USA including states of: CA, CO, FL, LA , MD, MI, MO, NJ, NY, OH, TN, VA, and WA.
  • Descripción del producto
    ORTHOFIX Firebird Spinal Fixation System, Pedicle Screw Spinal System, Reduction Case, Part #68-0111, Lot #16518-LC18. || Intended for use in conjunction with Multi-Axial Reduction Screw Assemblies. During assembly of a construct, the Anti-Splay Cap locks onto the Screw Body to prevent the Screw Body tabs from splaying (spreading apart). The Anti-Splay Cap is subsequently removed from the Screw Body after assembly of the construct. || The Anti-Splay Cap is a stainless steel machined instrument. The instrument is used within the Firebird Reduction Kit (Domestic, 44-9050) and the ICON Reduction Kit (International, 68-0010). || Product Code: NKB-Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease. Class II.
  • Manufacturer
    Orthofix Inc

Manufacturer

Orthofix Inc
  • Dirección del fabricante
    Orthofix Inc, 3451 Plano Parkway, Lewisville TX 75056-9453
  • Empresa matriz del fabricante (2017)
    Orthofix International Nv
  • Source
    USFDA