Events

Retiro De Equipo (Recall) de Device Recall Stryker Spine

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 Stryker Spine.

¿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
    63272
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0163-2013
  • Fecha de inicio del evento
    2012-07-05
  • Fecha de publicación del evento
    2012-10-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-01-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113355
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Causa
    Aviator drill bits are 10 mm longer than the reflex hybrid drill bits and are not interchangeable which could lead to over-drilling by as much as 10 mm.
  • Acción
    Stryker Spine sent an Urgent Medical Device Field Correction Notification letter beginning July 5, 2012, to all affected customers. Teh letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check the drill bit length in each respective drill guide prior to surgery to ensure the correct length protrudes through the guide. Customers with questions should call 201-760-8298. Customers were asked to report any adverse events or product quality problems to 1-888-457-7463.

Device

Device Recall Stryker Spine
  • Modelo / Serial
    E207315 Catalog number 48770610, 48770612, 48770616 All lots
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution.
  • Descripción del producto
    Aviator Drill Bit (10 mm, 12 mm, 14 mm, 16 mm, || Manufactured by: Stryker Spine SAS Z.1 Marticot -33610- Cestas France || +33 (0) 5.57.97.06.30 || http://www.stryker.com || Distributed in the USA by Stryker Spine || 2 Pearl Ct., Allendale NJ 07401-1677 USA || +1-201-750-8000 || Drill bits are reusable instruments, sterilized prior to use, used in conjunction with an Aviator Drill Guide to provide a pathway for screw insertion. The aviator Anterior Cervical Plating (ACP) System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation.
  • Manufacturer
    Stryker Spine

Manufacturer

Stryker Spine
  • Dirección del fabricante
    Stryker Spine, 2 Pearl Ct, Allendale NJ 07401-1611
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA