Events

Retiro De Equipo (Recall) de Stryker EMS Stair PRO

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 Medical Division 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
    Recall
  • ID del evento
    60422
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0943-2012
  • Fecha de inicio del evento
    2011-10-31
  • Fecha de publicación del evento
    2012-02-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-08-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105384
  • 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
    Stretcher, hand-carried - Product Code FPP
  • Causa
    The foot rest kit may have the wrong pivot spacers making the joint more susceptible to relaxation and prone to fatigue. there is a moderate risk of injury to the patient should the handles become detached during use.
  • Acción
    Stryker Medical spoke with all customers who received these shipments prior to 10/31/2011 requesting information on kits affected and recalled foot rest units installed. December 5, 2011 Urgent Medical Device Recall Letters, with instructions on how to to either install a new Foot Rest Kit ( enclosed ) or dispose of any kits that were not installed were sent to both customers who could have installed recalled foot rest units. Customers needing help or assistance with installation are asked to call Stryker Technical Support a 1-800-327-0770. Customers were to complete and return a postage paid postcard confirming receipt. Customers with questions or concerns are asked to contact Kristin Dudek at 269-389-6927 M-F m 8 a.m. - 5 p.m. (EST)

Device

Stryker EMS Stair PRO
  • Modelo / Serial
    Model 6251 and 6252, The Foot Rest Kit (pN 6252-700-003) Order numbers 2065939, 1739631, 2066066, 2066803, and 2066941.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution -- MI & MA.
  • Descripción del producto
    Foot Rest Kit (pN 6252700-003) for Models 6251 and 6252 Stryker (EMS Stair -PRO), OE 2065939, 1739631, 2066066, 6066803 and 20666941 with optional , Stryker Medical, Portage, MI 49002. || Intended to provide the patient greater comfort and a sense of security.
  • Manufacturer
    Stryker Medical Division of Stryker Corporation

Manufacturer

Stryker Medical Division of Stryker Corporation
  • Dirección del fabricante
    Stryker Medical Division of Stryker Corporation, 3800 East Centre Ave., Portage MI 49002
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA