Events

Retiro De Equipo (Recall) de Device Recall TOM(R) Bone Mill

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 Craniomaxillofacial Division.

¿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
    54663
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1202-2010
  • Fecha de inicio del evento
    2010-02-18
  • Fecha de publicación del evento
    2010-03-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-11-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88953
  • 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
    Tessier Osseous Microtome [TOM(R)] - Product Code LXH
  • Causa
    The firm has received 328 customer complaints for this device. most of the complaints were involving non-functioning of the ratcheting handle or complete device, or the presence of metal shavings or discoloration.
  • Acción
    An "URGENT MEDICAL DEVICE CORRECTION" letter dated February 18, 2010, was sent to the customers. The letter describes the product, problem, scope of affected products, potential patient risks and actions to be taken by the customers. The customers should review the letter with all users of the TOM(r) Bone Mill and follow the instructions on the proper inspection and maintenance of the device enclosed with the letter. The customers should fax the accountability form within 5 days to help Stryker ensure their receipt of the information. If the accountability form is not received, addition communication will be sent. If you have any urgent questions or concerns, please contact us at (269) 323-4258. Please ref: PFA #2009-128. Our normal business hours are Monday-Friday 8am-5pm (GMT+1:00) On 7/8/2010 the firm sent an Urgent Medical Device Recall letter to its customers. The letter stated thatt upon consultation with regulatory agencies outside of the United States, the firm had intiated a devicd removal. The letter instructed the customers to return any devices that they had to the recalling firm.

Device

Device Recall TOM(R) Bone Mill
  • Modelo / Serial
    all lots.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA and Belarus, Bulgaria, Denmark, Finland, Hungary, Jordan, Norway, Russia, Saudi Arabia and the UAE.
  • Descripción del producto
    Tessier Osseous Microtome TOM(R) Bone Mill, 01-15402, Stryker Portage, MI. || The TOM bone mill is designed to grind any type of cortical or cancellous bone.
  • Manufacturer
    Stryker Craniomaxillofacial Division

Manufacturer

Stryker Craniomaxillofacial Division
  • Dirección del fabricante
    Stryker Craniomaxillofacial Division, 750 Trade Centre Way Ste 200, Portage MI 49002-0482
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA