BEUDAMED
    FDA Recall Terminated

    Latitude", Tige Humerale, Humeral Stem, Medium 77 mm, Humeral Stem Right, For Cemented use only, Sterile R, REF 0030402, Tornier In. Edina, MN 55435 USA. The Tornier In. Latitude Elbow Prosthesis is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability following the effects of primary or secondary osteoarthritis and rheumatoid arthritis; correction of functional deformities; revision procedures where other treatments or devices have failed; treatment of fractures that are unmanageable using others techniques. The Tornier In. Latitude Elbow Prosthesis is intended for cemented use only.

    Recall: Z-3082-2011 · Initiated June 23, 2011

    Recall

    Recall Number
    Z-3082-2011
    Event Number
    59399
    Firm
    Tornier, Inc
    FEI Number
    3000718467
    Product Code
    JDB
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    June 23, 2011
    Posted
    August 29, 2011
    Terminated
    July 17, 2012
    Address
    7701 France Ave S, Ste 600, Edina, MN, 55435-3202

    Description

    Latitude", Tige Humerale, Humeral Stem, Medium 77 mm, Humeral Stem Right, For Cemented use only, Sterile R, REF 0030402, Tornier In. Edina, MN 55435 USA. The Tornier In. Latitude Elbow Prosthesis is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability following the effects of primary or secondary osteoarthritis and rheumatoid arthritis; correction of functional deformities; revision procedures where other treatments or devices have failed; treatment of fractures that are unmanageable using others techniques. The Tornier In. Latitude Elbow Prosthesis is intended for cemented use only.

    Reason

    Tornier has discovered that some models of the Tornier latitude Elbow Prosthesis (Small and Medium Humeral stems) were manufactured with a humeral screw that may not function as designed.

    Action

    Tornier, Inc. sent an "Urgent Product Correction" letter dated June 23, 2011. The letter was addressed to the doctors. The letter described the product and the problem. Doctors were insructed to monitor patients that have received the units for evidence of humeral screw loosening. For questions customers were instructed to contact the Customer Service Department at 1-888-494-7950.

    Distribution

    Nationwide Distribution including FL and MO

    Quantity

    3