Retiro De Equipo (Recall) de Device Recall Stryker SmartLife Large Aseptic Housing (7126120000)

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
  • Estado del evento
    Open, Classified
  • País 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
    Stryker instruments issued a notice of correction for an update to cleaning practices for the stryker smartlife large aseptic housings following complaints of deterioration to the housing and the top and bottom housing separating at the weld. using cleaning practices outside of the hifu could lead to housing separating at the weld.
  • Acción
    Stryker Instruments issued a written corrective notice via mail including a reminder to follow the IFU cleaning procedures for the Stryker SmartLife Large Aseptic Housings (7126-120-000). A small subset of customers have experienced product issues based on cleaning practices that are causing a deterioration of the housing, and speration of the top and bottom of the housing at the weld. Customers are instructed as follows: Several factors can adversely influence the structural integrity of the device. Below are some suggestions for you to review from the Heavy Duty Care Instructions/Instructions for Use to help reduce undue strain on the housing material: " Stryker recommends following sterilization/autoclaving instructions in the Care Instructions. " Stryker has identified that some customers are applying a pre-treatment to the device, please note that the Care Instructions advise the following that pertain to the application of pretreatments (Reference Page 12 of the Heavy Duty Care Instructions): ALWAYS make sure the detergent solution is completely rinsed from the interior and exterior of the equipment before drying the equipment. ALWAYS prepare the detergent solution according to the manufacturers recommendations. Pay particular attention to the concentration used and the total dispersion. " Stryker recommends when using an auto-washer, assure the appropriate parameters (rinse time/settings) are used as instructed in the Care Instructions (Reference Page 21 of the Heavy Duty Care Instructions). Additionally: Unload the washer-disinfector and visually inspect the equipment for remaining soil or detergent solution. If soil or detergent solution remains, repeat the cleaning procedure using fresh detergent solution. Utilizing cleaning practices outside of the IFU could lead to the housing separating at the weld. The health risk associated with the separation of the housing at the weld, is a potential breach in sterility, which may requ


  • Modelo / Serial
    Manufacture Start Date for Affected Lots: 18-Mar-2015 Manufacture End Date for Affected Lots: 31-Jan-2017
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Domestic: None Foreign: France, Germany
  • Descripción del producto
    Stryker SmartLife Large Aseptic Housing (7126-120-000)
  • Manufacturer


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