BEUDAMED
    FDA Enforcement Class II Terminated

    SC2316, Distal Femoral Augment with Screw Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems and revision of failed previous reconstructions.

    Recall: Z-2136-2013 · Reported September 11, 2013

    Enforcement

    Recall Number
    Z-2136-2013
    Event ID
    65823
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stelkast Co
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    September 11, 2013
    Initiation Date
    June 24, 2013
    Classification Date
    September 3, 2013
    Termination Date
    October 8, 2014
    Address
    200 Hidden Valley Rd, N/A, Mcmurray, PA, 15317-2659, United States

    Description

    SC2316, Distal Femoral Augment with Screw Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems and revision of failed previous reconstructions.

    Reason

    The firm became aware of an incident relating to a breach of sterility in the sterility barrier packaging of SC2316, Distal Femoral Augment with Screw.

    Code Info

    Part number SC2316-3-5 with lot number 22389-111609. Part number SC2316-4-5 with lot number 22587-111609. Part number SC2316-5-5 with lot number 23214-111609.

    Distribution

    Nationwide Distribution including TX, VA, OK, and PA

    Quantity

    11