BEUDAMED
    FDA Recall Terminated

    Stryker Renaissance Series/Advantage Series PACU wheeled stretcher, Model 1509, Stryker Medical, Portage, MI 49002

    Recall: Z-0236-2008 · Initiated November 15, 2004

    Recall

    Recall Number
    Z-0236-2008
    Event Number
    37214
    Firm
    Stryker Medical Div. of Stryker Corporation
    FEI Number
    1831750
    Product Code
    FPO
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    November 15, 2004
    Posted
    November 10, 2007
    Terminated
    October 27, 2010
    Address
    3800 E. Centre Ave., Portage, MI, 49002

    Description

    Stryker Renaissance Series/Advantage Series PACU wheeled stretcher, Model 1509, Stryker Medical, Portage, MI 49002

    Reason

    The brake cams may crack or develop excessive wear, resulting in the brakes not locking the wheels, or the stretcher not being locked firmly in position.

    Action

    The firm issued an Urgent Medical Device Correction Letter dated 9/24/07, to each consignee informing them of the problems, that the brakes on each affected stretcher needed to be inspected/tested and removed from service if brake problems were discovered, and that a Stryker service representative would be in contact to replace the brakes.

    Distribution

    Worldwide-USA, Argentina, Australia, Brazil, Canada, Chile, China, Dubai, France, India, Italy, Japan, Germany, Greece, Hong Kong, Korea, Latin America, Malaysia, Mexico, Netherlands, Poland, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, and United Kingdom.

    Quantity

    81,367 (61,708 U.S. and 19,569 ex-U.S.) for all models.