BEUDAMED
    FDA Recall Terminated

    iLink Bone Void Filler. Packaged in a double Tyvek pouch, then placed in a box. Model Number: 50-05-0010, Exp. 2010-04.

    Recall: Z-1965-2009 · Initiated August 26, 2008

    Recall

    Recall Number
    Z-1965-2009
    Event Number
    52798
    Firm
    Theken Spine LLC
    FEI Number
    3002498892
    Product Code
    MQV
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    August 26, 2008
    Posted
    September 3, 2009
    Terminated
    March 9, 2012
    Address
    1800 Triplett Blvd, Akron, OH, 44306-3311

    Description

    iLink Bone Void Filler. Packaged in a double Tyvek pouch, then placed in a box. Model Number: 50-05-0010, Exp. 2010-04.

    Reason

    Failure to label the product properly. Additionally, 15 pieces were reworked and the expiration date was misprinted as 2011-04 instead of the actual date of 2010-04.

    Action

    Theken Spine, LLC contacted the Consignee August 26, 2008 via telephone and instructed them to inventory their stock and return affected product to the firm. For further questions, contact Theken Spine, LLC at 1-330-475-8662.

    Distribution

    Nationwide Distribution -- TX.

    Quantity

    22 units