BEUDAMED
    FDA Recall Terminated

    BioPro Femoral Head 28 mm -6 mm, Item 19003. Orthopedic femoral head for implantation.

    Recall: Z-0163-2012 · Initiated September 21, 2011

    Recall

    Recall Number
    Z-0163-2012
    Event Number
    60143
    Firm
    Biopro, Inc.
    FEI Number
    1832656
    Product Code
    JDI
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    September 21, 2011
    Posted
    November 4, 2011
    Terminated
    February 15, 2013
    Address
    2929 Lapeer Rd, Port Huron, MI, 48060-2558

    Description

    BioPro Femoral Head 28 mm -6 mm, Item 19003. Orthopedic femoral head for implantation.

    Reason

    BioPro Femoral Head Outer Packaging was found lacking proper seal ,compromising sterility.

    Action

    Biopro, Inc notified all affected customers via telephone on September 21, 2011 with instructions to quarantine and return affected product to the manufacturer. The firm sent a follow up "RECALL NOTICE" dated September 29, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter gives instructions on how to return affected product. Contact Customer Service at 1-800-252-7707 for questions regarding this recall.

    Distribution

    USA (nationwide) including the states of FL, MI, and TX.

    Quantity

    4 units