Events

Retiro De Equipo (Recall) de Depuy Spine Mountaineer OCT Spinal System Screw Caddy Set

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 DePuy Spine, 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
    56894
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0818-2011
  • Fecha de inicio del evento
    2010-10-02
  • Fecha de publicación del evento
    2010-12-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-04-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94878
  • 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
    Tray, Surgical - Product Code LRP
  • Causa
    The scale which serves as a secondary means of identifying screw length is incorrectly etched on the screw caddy.
  • Acción
    Depuy Spine issued an "URGENT-VOLUNTARY PRODUCT RECALL NOTIFICATION" via e-mail on October 2, 2010 to customers. The notification describes the product, problem and action to be taken by customers. The customers were instructed to please distribute this information to appropriate personnel at their facility and return any caddies that they may have to their local distributor for DePuy Spine products. Depuy will return devices to customer promptly (within two business days), after reworking the devices by removing the scale altogether. Once the product is fully corrected, Depuy will provide the customers with a new and updated unit with the corrected scale markings. If you should have any questions or concerns regarding this action, please contact DePuy Spine Customers Service at 800-227-6633.

Device

Depuy Spine Mountaineer OCT Spinal System Screw Caddy Set
  • Modelo / Serial
    Not lot coded
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: USA including states of: AR, AZ, CA, FL, HI, IA, IL, KY, LA, MA, MI, MN, MO, NC, NY OH, PA, TN, TX, VA, and WA.
  • Descripción del producto
    Depuy Spine Mountaineer OCT Spinal System Screw Caddy, Non Sterile || Product Code: 2883-90-420 || The MOUNTAINEER Screw caddy is intended to act as a holder in an implant set for implantable screws prior to use in surgery. Further, the caddy provides a means to organize the screws in accordance with the length of the screws.
  • Manufacturer
    DePuy Spine, Inc.

Manufacturer

DePuy Spine, Inc.
  • Dirección del fabricante
    DePuy Spine, Inc., 325 Paramount Drive, Raynham MA 02767
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA