BEUDAMED
    FDA Recall Terminated

    Stryker Medical Stair-PRO Stair Chair with wheels and a track system, patient transport device, Model 6252.

    Recall: Z-0149-2010 · Initiated September 2, 2009

    Recall

    Recall Number
    Z-0149-2010
    Event Number
    53251
    Firm
    Stryker Medical Div. of Stryker Corporation
    FEI Number
    1831750
    Product Code
    FPP
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 2, 2009
    Posted
    November 9, 2009
    Terminated
    February 16, 2011
    Address
    3800 East Centre Ave., Portage, MI, 49002

    Description

    Stryker Medical Stair-PRO Stair Chair with wheels and a track system, patient transport device, Model 6252.

    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.

    Distribution

    Worldwide distribution - Colorado, Ohio, Wisconsin, and Germany, Italy, Netherlands, Poland and Switzerland.

    Quantity

    165