BEUDAMED
    FDA Recall 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 · Initiated June 24, 2013

    Recall

    Recall Number
    Z-2136-2013
    Event Number
    65823
    Firm
    Stelkast Co
    FEI Number
    3004142400
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 24, 2013
    Posted
    September 3, 2013
    Terminated
    October 8, 2014
    Address
    200 Hidden Valley Rd, Mcmurray, PA, 15317-2659

    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.

    Action

    Stelkast called and emailed all customers on June 24, 2013, to notify them of the recall. Customers were asked to recover all affected products from their inventory and return them to Stelkast. Customers were instructed to contact Stelkast Customer Service for a Return Authorization (RA) Number prior to shipment to Stelkast. Customers with questions were instructed to call 1-888-273-1583. For questions regarding this recall call 724-941-6368.

    Distribution

    Nationwide Distribution including TX, VA, OK, and PA

    Quantity

    11