BEUDAMED
    FDA Enforcement Class II Terminated

    LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 LEFT, A/P 62 MM, M/L 70 MM, REF 71421375 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, 5. Constrained and hinge knee systems are designed for use in patients in primary and revision surgery. The LEGION Hinge Knee System is for cemented use only.

    Recall: Z-2094-2016 · Reported July 6, 2016

    Enforcement

    Recall Number
    Z-2094-2016
    Event ID
    74271
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smith & Nephew, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 6, 2016
    Initiation Date
    May 26, 2016
    Classification Date
    June 29, 2016
    Termination Date
    August 16, 2019
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804, United States

    Description

    LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 LEFT, A/P 62 MM, M/L 70 MM, REF 71421375 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, 5. Constrained and hinge knee systems are designed for use in patients in primary and revision surgery. The LEGION Hinge Knee System is for cemented use only.

    Reason

    The surface inside of the femoral component, where cement is applied for adhesion, is below specification.

    Code Info

    Lot codes: 15KM09184,15LM08835,15LM08837,15LM08839,15LM08840

    Distribution

    Worldwide Distribution and US Nationwide including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, South Africa, Sweden, and UK.

    Quantity

    10 units