Retiro De Equipo (Recall) de Device Recall Zimmer Reconstruction System Tenaculum Straight Tine Straight 9 inch

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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Instrument, compression - Product Code HWN
  • Causa
    The firm determined that the recalled instruments were manufactured using the wrong grade of material. as manufactured, the instruments are more brittle, increasing the potential for fracture.
  • Acción
    Zimmer sent an Urgent Device Recall letter dated February 16, 2010, to all affected customers. The letter identified the product, the problem, and the action the customers should take. Customers were instructed to monitor all potentially affected patients through regular office consultations. Ensure Zimmer Reconstruction System Tenaculum System Instrument Users at their facility were informed of the urgent device recall. Locate all instruments and quarantine them immediately. Count all affected product in their territory and record the data on the Inventory Return Certification Form included with the letter. Fax a copy of the completed Inventory Return Form to: Zimmer, Inc. at (574) 372-4265. Return the recalled product along with the original completed Inventory Return Certification Form to: Zimmer Distribution Center Attn: Product Service 1777 West Center Street Warsaw, IN 46580 For questions customers were instructed to contact their Zimmer Sales Representative. For questions regarding this recall call 1 - (800) 613-6131.


  • Modelo / Serial
    lot #'s: 60806992 and 60921166
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - USA including AL, FL, HI, IA, IL, KS KY, LA, MI, MO, MS, NC, ND, NJ, OH, OK, OR, PA, TN, TX, UT, VA, WA, AND WI and the countries of Australia, Canada, Central or South America, China, Germany, India, Italy, Saudi Arabia, and UK,
  • Descripción del producto
    Zimmer Reconstruction System Tenaculum Straight Tine Straight 9 inch, Item # 00-1179-023-00, Zimmer Inc., Warsaw, IN. || Intended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.
  • Manufacturer


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