Events

Retiro De Equipo (Recall) de Zimmer Gender Solutions Natural Knee Flex System, Prolong Articular Surface,

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 Zimmer 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
    53399
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0219-2010
  • Fecha de inicio del evento
    2009-10-08
  • Fecha de publicación del evento
    2009-11-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-05-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85423
  • 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
    Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/ - Product Code JWH
  • Causa
    The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
  • Acción
    An "Urgent: Field Correction" dated October 8, 2009 was issued to Consignees. The notification letter described the affected product, issue, health risks and actions for customers to take. The letter notified consignees of a changed to the surgical technique, to include the use of a new peripheral rib impactor tool. Notifications of this field notification were sent to all affected direct accounts of Zimmer, Inc. Contact your Zimmer Sales Representative if you have any questions regarding this action. For shipping assistance, questions or assistance in notifying your accounts about the field correction please contact Zimmer, Inc. at 1-800-613-6131.

Device

Zimmer Gender Solutions Natural Knee Flex System, Prolong Articular Surface,
  • Modelo / Serial
    Lots 60930904, 60943115, 60943116, 60947738, 60954144, 60954158, 60958278, 60964463, 60964464, 60964465, 60975020, 60975035, 60981792, 60981809, 60987824, 60987825, 60988225, 60992947, 60992948, 60992949, 60992950, 60992951, 60992952, 60992953, 60993909, 60993910, 61005438, 61017699, 61023597, 61023616, 61027883, 61027917, 61036347, 61045083, 61051477, 61051478, 61058583, 61064806, 61069415, 61075242, 61078756, 61078757, 61085876, 61091183, 61096360, 61096361, 61101458, 61101459, 61106560, 61106561, 61106562, 61114167, 61114179, 61117036, 61117037, 61117038, 61117046, 61117052, 61122284, 61122285, 61126522 and 61126523.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution -- United States, Austria, Belgium, France, Germany, Japan, Spain and Switzerland.
  • Descripción del producto
    Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1 or 2, right, 9 MM height, for use with baseplate size 1, 2, sterile, Zimmer, Warsaw, IN; REF 00-5424-021-09. || The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals.
  • Manufacturer
    Zimmer Inc.

Manufacturer

Zimmer Inc.
  • Dirección del fabricante
    Zimmer Inc., 345 E Main St, Warsaw IN 46580-2746
  • Source
    USFDA