Retiro De Equipo (Recall) de Device Recall DePuy Attune Impaction Handle Warsaw

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 Orthopaedics, 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Causa
    Depuy orthopaedics, inc. is issuing a recall notice for nine lots of the attune" impaction handle due to the potential for the handle trigger to break during surgery. the attune impactor is provided as a part of a set of tools and is designed specifically for the installation of the attune knee.
  • Acción
    DePuy Orthopaedics, Inc. sent an URGENT INFORMATION - MEDICAL DEVICE RECALL NOTICE letter dated March 16, 2012 to all consignees affected which extended to the Depuy Distributor level, surgeon and hospital level. The affected DePuy Distributors were notified via email on March 16, 2012. The sales representatives notify hospitals and surgeons by mail or in person with written communication. The letter identified the affected product, reason for recall notice, clinical implications and actions to be taken. Consignees were instructed to complete and return the Response cards to DePuy by fax to 574-372-7567 or email When the new impaction handles are available, the DePuy sales representative will be responsible for providing the new handles, removing and returning the affected handles. For product-related questions, please contact your local DePuy Orthopaedics sales representative. For clinical-related questions from surgeons, please contact DePuy's Scientific Information Office at 1-888-554-2482 (M-F; 8 am - 5 pm EST.) For questions about recall information provided, please contact Katie Seppa, Manager of Customer Quality, 574-372-7333 (M-F; 8 am - 5 pm EST.)


  • Modelo / Serial
    Catalog: 254401010 Lot numbers: NW102815, NW102817, NW102816, NW102812, NW102814, NW102818, NW102819, NW102820, and NW104367.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    USA Nationwide Distribution including the states of: MA, MD, IL, IA, MN, WA, CA, FL, NC, VA, and IN.
  • Descripción del producto
    DePuy Attune Impaction Handle Warsaw, IN 46582 || Packaging: Product is packed within a polyethylene bag, with protection added as needed for sharp and/or fragile points. || Product Usage: The ATTUNE Impaction handle is intended to act as a removable interface for several of the instruments that may be used throughout a procedure. The Attune Impaction Handle is used to impact, insert, and extract various Attune Instruments. The handle interfaces with the Keel Punch, Tibial Tower, Evaluation Bullet, Fixed Bearing Tibial Impactor, Rotating Platform Tibial Impactor and the Femoral Impactor.
  • Manufacturer


  • Dirección del fabricante
    DePuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • Empresa matriz del fabricante (2017)
  • Source