Events

Recall of Device Recall Stryker Medical StairPRO Evacuation Chair

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Medical Div. of Stryker Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    50178
  • Event Risk Class
    Class 2
  • Event Number
    Z-0650-2009
  • Event Initiated Date
    2008-11-18
  • Event Date Posted
    2009-02-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75006
  • Notes / Alerts
    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.
  • Extra notes in the data
    patient transport device, - Product Code FPP
  • Reason
    Handle could come off. the bolts may back out over time, resulting in a risk of dropping the patient and/or injury to transport personnel, a delay in medical treatment, or a delay in evacuation.
  • Action
    Consignees were notified by Urgent Medical Device Correction letter dated 11/18/08 and given the serial numbers of their units, an upgrade kit and instructions for performing replacement of the bolts. Consignees were informed Stryker will perform the upgrade if requested.

Device

Device Recall Stryker Medical StairPRO Evacuation Chair
  • Model / Serial
    Serial numbers 080940895, 080940896, 080940578, 080940614, 080940615, 080940616, 080940618, 080940619, 080940620, 080940621, 080940623, 080940624, 080940625, 080940626, 080940628, 080940880, 080940571, 080940572, 080940573, 080940574, 080940575, 080940576, 080940629, 080940630, 080940599, 080940554, 080940555, 080940887, 080940888, 080940889, 080940890, 080940891, 080940892, 080940893, 080940894, 800940881, 080940772, 080940773, 080940774, 080940564, 080940565, 080940566, 080940850, 080940856, 080940556, 800940557, 080940558, 080940559, 080940560, 080940561, 800940562, 080940563, 080940633, 080940634, 080940635, 080940636, 080940245, 080940246, 080940851, 080940852, 080940853, 080940854, 080940846, 080940847, 080940848, 080940849, 080940810, 080940811, 080940812, 080940813, 080940814, 080940815, 080940577, 080940631, 080940632, 080940617, 080940622, 080940627, 080940818, 080940857, 080940882, 080940897, 080940816, 080940817, 080940567, 080940568, 080940569, 080940570, 080940579, 080940800, 080940801, 080940802, 080940878, 080940879, 080940855, 080940883, 080940884, 080940885, 080940886, 080940637, 080940638 and 080940803.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA, India, Netherlands and United Kingdom.
  • Product Description
    Stryker Medical Stair-PRO Evacuation Chair civilian use stair chair, patient transport device, Model 6253.
  • Manufacturer
    Stryker Medical Div. of Stryker Corporation

Manufacturer

Stryker Medical Div. of Stryker Corporation
  • Manufacturer Address
    Stryker Medical Div. of Stryker Corporation, 3800 E. Centre Ave., Portage MI 49002
  • Source
    USFDA