Retiro De Equipo (Recall) de Stryker SmartLife Large Aseptic Housing

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 Instruments Div. of Stryker Corporation.

¿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, surgical, orthopedic, ac-powered motor and accessory/attachment - Product Code HWE
  • Causa
    The smartlife aseptic housings are being recalled in that the top section of the housing may separate from the bottom section due to insufficient welding.
  • Acción
    On October 8, 2014, Stryker Instruments issued "URGENT MEDICAL DEVICE RECALL NOTIFICATION" to their consignees. Notification included affected product description, reason for recall, risk to health, and actions to be taken by the customer/user. The customer/user were instructed to immediately review this recall notification, check all stock areas; discontinue use of any product which shows sign of cracking or damage at the weld; and complete and return the enclosed Business Reply Form (BRF) via fax to Stryker Instruments Regulatory Department, 866-521-2762 or scan and email a copy to Upon receipt of completed BRF, a replacement product will be shipped and the customer/users, upon receipt of replacement product, are to remove and return all recalled product from use and replace them with new product. For questions regarding this recall, please contact Stryker Instruments: at 269-389-4518 or email:


  • Modelo / Serial
    Part Number 7126-120-000; All lot numbers from 13027 to 14093
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution: US (nationwide) WI, MD, NY, NM, AZ, GA, CA, MN, DE, PA, TX, MT, MI, KS, KY, WY, IL; and countries of: Australia, Canada, Sweden, Netherlands, France Switzerland, India, Japan, Poland, South Africa, England, and Hong Kong.
  • Descripción del producto
    Stryker SmartLife Large Aseptic Housing || REF 7126-120-000 || Rx Only || The SmartLife" Aseptic Housings are designed to be used in conjunction with the SmartLife Non-Sterile Batteries to provide power for System 7 Handpieces, Cordless Driver 4 Handpiece, and Sabo2 Sagittal Saw Handpiece.
  • Manufacturer


  • Dirección del fabricante
    Stryker Instruments Div. of Stryker Corporation, 4100 E Milham Ave, Portage MI 49002-9704
  • Empresa matriz del fabricante (2017)
  • Source