BEUDAMED
    FDA Recall Terminated

    EBI Trochanteric 11mm Long Nail.

    Recall: Z-0012-06 · Initiated June 24, 2005

    Recall

    Recall Number
    Z-0012-06
    Event Number
    32813
    FEI Number
    2242816
    Product Code
    JDS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 24, 2005
    Posted
    October 7, 2005
    Terminated
    July 3, 2006
    Address
    EBI, L.P. 100 Interpace Pkwy, Parsippany, NJ, 07054-1149

    Description

    EBI Trochanteric 11mm Long Nail.

    Reason

    Upon evaluation, the firm found that the fatigue strength of these nails was below the required value as specified in the design specification.

    Action

    The firm sent out via e-mail notification to their field representatives on 6/27/2005 to identify, remove and return to EBI all affected product from their inventories. One direct customer, Dr. Maylack was sent a recall letter on 7/7/2005.

    Distribution

    There are 9 sales representatives that are instructed to remove and return the EBI nail from nationwide customers.

    Quantity

    102 nails