Events

Retiro De Equipo (Recall) de Device Recall Zimmer Most Hinged Tibia Baseplate Spacer

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
    51039
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0996-2009
  • Fecha de inicio del evento
    2009-01-29
  • Fecha de publicación del evento
    2009-03-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-11-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=78236
  • 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
    Knee Femorotibial Metal/Polymer Constrained Cemented Prosthesis - Product Code KRO
  • Causa
    The package contains 11 mm screws instead of the specified 6 mm screws.
  • Acción
    The consignee in Germany was notified by an Urgent: Device Recall letter dated 1/29/09, and delivered by email on 2/19/09. The letter stated the reason for the recall and clinical implications. The firm asked the consignee to stop using the provisional and quarantine it immediately; physically count all affected product and record data on the Inventory Return Certification Form included with letter; fax a copy of the completed form to Zimmer, Inc at 574-371-8603; request an IRA from Lindsey Arnett; and return recalled product along with completed Inventory Return Certification Form and IRA to Simmer Distribution Center. The letter states that credit will be issued upon receipt of the returned product. Also, if product has been further distributed, a copy of the recall letter should be provided to the customers. Questions or assistance should be directed to Zimmer, Inc at 1-800-613-6131.

Device

Device Recall Zimmer Most Hinged Tibia Baseplate Spacer
  • Modelo / Serial
    Lot 1635572.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    International Distribution only -- Country of Germany.
  • Descripción del producto
    Zimmer Most Hinged Tibia Baseplate Spacer, size 1, 6 mm, sterile, Zimmer, Warsaw, IN; REF 5020-06-001. || Component used to augment uni- and bi-compartmental defects and is manufactured from Ti-6A1-4V Alloy.
  • Manufacturer
    Zimmer Inc.

Manufacturer

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