BEUDAMED
    FDA Recall Terminated

    FormPutty Bone Void Filler 10cc The product is sealed in a foil pouch and then placed in a box following sterilization. Part # 50-07-0100 Is a flowable resorbable porous bone void filler composed of beta tricalcium phosphate and other calcium phosphates.

    Recall: Z-2375-2008 · Initiated July 11, 2008

    Recall

    Recall Number
    Z-2375-2008
    Event Number
    49018
    Firm
    Theken Spine LLC
    FEI Number
    3002498892
    Product Code
    MQV
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    July 11, 2008
    Posted
    September 18, 2008
    Terminated
    September 20, 2011
    Address
    1800 Triplett Blvd, Akron, OH, 44306-3311

    Description

    FormPutty Bone Void Filler 10cc The product is sealed in a foil pouch and then placed in a box following sterilization. Part # 50-07-0100 Is a flowable resorbable porous bone void filler composed of beta tricalcium phosphate and other calcium phosphates.

    Reason

    The patient label inside the package has an expiration date of 2008-06 when the actual expiration date is 2010-06.

    Action

    In a letter dated July 11, 2008, the firm asked their customers to check their inventory for the suspect product. If found they are to return the product for credit or replacement. The firms asks customers to contact them if any units were used for surgery and they will send the correct patient labels. If additional information is needed, customers are to contact Theken Spine Regulatory Affairs or the Quality Department.

    Distribution

    Nationwide Distribution --- including states of FL, OH, TX, and UT.

    Quantity

    33 syringes