BEUDAMED
    FDA Recall Terminated

    VS-1000 Senator Prosthetic Foot, (Categories 5 and 6, sizes 22-30 cm, both Left and Right) Applied Composite Technology, Gunnison, UT.

    Recall: Z-1149-2007 · Initiated June 20, 2007

    Recall

    Recall Number
    Z-1149-2007
    Event Number
    38289
    Firm
    Applied Composite Technology
    FEI Number
    3004737223
    Product Code
    ISH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 20, 2007
    Posted
    August 7, 2007
    Terminated
    June 5, 2008
    Address
    425 East 400, North Gunnison, UT, 84634

    Description

    VS-1000 Senator Prosthetic Foot, (Categories 5 and 6, sizes 22-30 cm, both Left and Right) Applied Composite Technology, Gunnison, UT.

    Reason

    Prosthetic foot device may loosen or separate during use; due to structural inconsistency that may cause a pyramid failure.

    Action

    On 06/20 and 06/21/2007 all recipients of the affected Senators were notified by telephone. They were asked to return all suspect prostheses for replacement. Follow-up emails and fax letters (6/21/07) were also sent.

    Distribution

    Worldwide Distribution- USA including states of CA, CO, FL, IL, MI, MN, MS, NC, NY, OR, PA, SC, TN, TX, VA, WA. VA facilities in CA and MI. Foreign distribution to Australia, Canada, Germany, Russia, South Africa, South Korea, and UK.

    Quantity

    97 units