BEUDAMED
    FDA Recall Terminated

    KRD1 PedFuse Rods, Model: IM80100-13 Rev B Product Usage: Pedicle rods are cylindrical rods which act as a linking mechanism between pedicle screws. The rod sits with the pedicle screw tulip and they are locked into place with a set screw or locking cap. The rod may be placed along several pedicle screws. Component rods are used during implantation of pedicle screw system devices intended to provide immobilization and stabilization of spinal segments of skeletally mature patients.

    Recall: Z-1737-2013 · Initiated December 30, 2011

    Recall

    Recall Number
    Z-1737-2013
    Event Number
    64989
    Firm
    SpineFrontier, Inc.
    FEI Number
    3005977257
    Product Code
    MNI
    Status
    Terminated
    Root Cause
    Vendor change control
    Initiated
    December 30, 2011
    Posted
    July 16, 2013
    Terminated
    January 8, 2014
    Address
    500 Cummings Ctr, Ste 3500, Beverly, MA, 01915-6516

    Description

    KRD1 PedFuse Rods, Model: IM80100-13 Rev B Product Usage: Pedicle rods are cylindrical rods which act as a linking mechanism between pedicle screws. The rod sits with the pedicle screw tulip and they are locked into place with a set screw or locking cap. The rod may be placed along several pedicle screws. Component rods are used during implantation of pedicle screw system devices intended to provide immobilization and stabilization of spinal segments of skeletally mature patients.

    Reason

    One of the rods in each of two test constructs did not meet fatigue requirement as outlined in ASTM F1717-04 dynamic compression testing 5 million cycles.

    Action

    SpineFrontier issued a Recall Notification to the affected distributor via telephone. The distributor was instructed to return the affected product for a replacement product.

    Distribution

    USA Nationwide Distribution including the state of TX

    Quantity

    2 rods