Events

Retiro De Equipo (Recall) de Ratcheting Torque Limiting Handle

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
    58473
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3162-2011
  • Fecha de inicio del evento
    2011-04-01
  • Fecha de publicación del evento
    2011-09-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99424
  • 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
    Upon reaching torque limit, there is a possibility the product may jam or exhibit a ratchet direction switch from forward to reverse.
  • Acción
    Orthofix, Inc. sent an "URGENT PRODUCT RECALL NOTIFICATION" letter dated April 1, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to identify and remove the affected product from use. Customers were advised to use the combination of the Ratching R Handle and the Set Screw Driver if they experience problems with the Ratching Torque Limiting Handle. A Tracking and Verification form was attached for customers to complete and return to the Orthofix Inc. Regulatory Affairs Department via fax at 214-937-3322. Contact your Account Services Representative at 888-298-5700 for questions regarding the removal and return of the affected product.

Device

Ratcheting Torque Limiting Handle
  • Modelo / Serial
    All serial numbers.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution-USA (nationwide) and Puerto Rico and the countries of Australia and Germany.
  • Descripción del producto
    Ratcheting Torque Limiting Handle, Catalog Number 52-1012, Orthofix Spinal Implants, Firebird Spinal Fixation System, Firebird Spinal Fixation System DDD Instrument Case. || Product is intended for use with the Set Screw Driver (52-1061) and Adjustable Counter Torque Wrench (52-1265) to perform the final tightening of set screws in a spinal implant construct.
  • Manufacturer
    Orthofix, Inc.

Manufacturer

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