BEUDAMED
    FDA Recall Terminated

    Threaded Tip GD Pin 1/8in x 9in Pk 5 Sterile found in Uniflex Profile Tibial Nail P/N 329640.

    Recall: Z-0918-05 · Initiated March 16, 2005

    Recall

    Recall Number
    Z-0918-05
    Event Number
    31822
    FEI Number
    2242816
    Product Code
    HXI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 16, 2005
    Posted
    June 22, 2005
    Terminated
    June 30, 2006
    Address
    EBI, L.P. 100 Interpace Pkwy, Parsippany, NJ, 07054-1149

    Description

    Threaded Tip GD Pin 1/8in x 9in Pk 5 Sterile found in Uniflex Profile Tibial Nail P/N 329640.

    Reason

    The wire appears to be soft and the wire bent during insertion. This causes kinks in which the reamer could not pass over the bent/kinked wire.

    Action

    The firm distributed a recall letter to their EBI Fracture Sales Representatives and their EBI Trauma Distributors on 3/16/2005.

    Distribution

    These devices are distributed nationwide to sales representatives who provide the product directly to the hospital/physician at the time of the surgery. The product was also distributed to Italy and Spain. There are no government accounts.

    Quantity

    152 units