BEUDAMED
    FDA Recall Terminated

    Re-Flex VSP and Low Profile Re-Flex VSP external prosthetic foot modules with integrated shock absorber, Model numbers RFXS0002, RFXS0003, RFLS0006 and RFL50007

    Recall: Z-0468-2007 · Initiated November 3, 2006

    Recall

    Recall Number
    Z-0468-2007
    Event Number
    36883
    Firm
    Ossur Grjothals 5 Reykjavik Ireland
    FEI Number
    3003764610
    Product Code
    ISH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 3, 2006
    Posted
    January 10, 2007
    Terminated
    May 28, 2008

    Description

    Re-Flex VSP and Low Profile Re-Flex VSP external prosthetic foot modules with integrated shock absorber, Model numbers RFXS0002, RFXS0003, RFLS0006 and RFL50007

    Reason

    Inner Tube Breakage: distributed low quality units can lead to breakage of the inner tube, resulting in an abrupt rotation of the shock module, compromising function and stability of the prosthetic foot

    Action

    By letter on Nov 9, 2006. An initial letter was sent to all involved customers stating the invoice number, the purchase order number and the original shipping date. The problem is explained and the detailed exchange process is outlined. Contact information is included (ref. enclosure 2.1). At the same time as the mailing, all customers are being contacted proactively by a customer service representative.

    Distribution

    Nationwide in US plus Worldwide distribution in Canada, Austria, Switzerland, Czech Republic, Germany, Spain, France, United Kingdom, Greece, Israel, Italy, Netherlands and Norway.

    Quantity

    138 worldwide (86 in US)