Recall of Stryker Medical StairPRO Stair 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
    53251
  • Event Risk Class
    Class 2
  • Event Number
    Z-0149-2010
  • Event Initiated Date
    2009-09-02
  • Event Date Posted
    2009-11-09
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2011-02-16
  • Event Source
    USFDA
  • Event Source URL
  • 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
    Stretcher, Hand-Carried - Product Code FPP
  • Reason
    The front of the handle may become detached from the chair, which could result in a patient fall or an operator injury.
  • Action
    Consignees were sent a letter titled URGENT MEDICAL DEVICE CORRECTION dated 9/9/09, advising them of the problem and to remove the devices from service until they have been repaired. U.S. customers were notified that Stryker will complete the correction while international customers were sent a kit with instructions for completion of the correction. International consignees were told that Stryker will complete the correction if the consignee does not feel comfortable in doing so. Questions or comments regarding this issue should be addressed to Sarah Marie Puterbaugh of Stryker Medical at (800) 869-0770 ext. 6902.

Device

  • Model / Serial
    Serial numbers 080340370, 080340371, 080340372, 080340373, 080340374, 080340375, 080340376, 080340377, 080340378, 080340379, 080340380, 080340381, 080340382, 080340383, 080340384, 080340385, 080340386, 080340387, 080340388, 080340389, 080439732, 080539750, 080539751, 080539752, 080539755, 080539756, 080539757, 080540101, 080540102, 080540103, 080540104, 080540105, 080540106, 080540107, 080540108, 080540109, 080540110, 080540111, 080540112, 080540113, 080540114, 080540115, 080541118, 080541119, 080541120, 080541121, 080541122, 080541123, 080541124, 080541125, 080541126, 080541127, 080541128, 080541129, 080541130, 080541131, 080541132, 080541163, 080541164, 080541165, 080541166, 080541167, 080541168, 080541169, 080541170, 080541171, 080541172, 080541173, 080541174, 080541175, 080541176, 080541177, 080541188, 080541189, 080541190, 080541223, 080541224, 080541225, 080541226, 080541227, 080541228, 080541229, 080541230, 080541231, 080541232, 080541233, 080541234, 080541235, 080541236, 080541237, 080541238, 080541239, 080740000, 080839665, 080839666, 080839667, 080940219, 080940220, 080940221, 080940598, 080940753, 080940754, 080940755, 080940756, 080940757, 080940758, 080940759, 081040840, 081040841, 081040842, 081040843, 081139364, 081139365, 081139366, 081139367, 081139368, 081139369, 081139370, 081139371, 081139372, 081139373, 081139374, 081139375, 081139376, 081139377, 081139378, 081139664, 081140082, 081140083, 081140084, 081140085, 090140100, 090140101, 090140102, 090140103, 090140104, 090140105, 090239555, 090239587, 090240122, 090240123, 090240124, 090240125, 090240126, 090240127, 090240128, 090240129, 090240130, 090240131, 090240132, 090240133, 090240134, 090240135, 090240136, 090240137, 090240138, 090240139, 090240140, 090240141, 090240488, 090240988, 090240989, 090240990, 090240991 and 090240992.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution - Colorado, Ohio, Wisconsin, and Germany, Italy, Netherlands, Poland and Switzerland.
  • Product Description
    Stryker Medical Stair-PRO Stair Chair with wheels and a track system, patient transport device, Model 6252.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Stryker Medical Div. of Stryker Corporation, 3800 East Centre Ave., Portage MI 49002
  • Manufacturer Parent Company (2017)
  • Source
    USFDA