BEUDAMED
    FDA Enforcement Class II Terminated

    Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B The caddy holds, in an organized fashion within the case, 8mm and 9mm pedicle screws used during implantation of pedicle screw system devices intended to provide immobilization and stabilization of spinal segments of skeletally mature patients

    Recall: Z-1869-2013 · Reported August 7, 2013

    Enforcement

    Recall Number
    Z-1869-2013
    Event ID
    64987
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    SpineFrontier, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 7, 2013
    Initiation Date
    October 5, 2012
    Classification Date
    August 1, 2013
    Termination Date
    July 29, 2015
    Address
    500 Cummings Ctr Ste 3500, N/A, Beverly, MA, 01915-6516, United States

    Description

    Caddy - PedFuse, Screw Caddy, 8MM and 9MM, Part Number: 11-80009 Rev. B The caddy holds, in an organized fashion within the case, 8mm and 9mm pedicle screws used during implantation of pedicle screw system devices intended to provide immobilization and stabilization of spinal segments of skeletally mature patients

    Reason

    Two sections that are designated for the 8mm and 9mm screws were switched; the holes that hold the 8mm screws are designed for 9mm screws, and the holes that hold the 9mm screws are designated for 8mm screws.

    Code Info

    31176, 018652, 018645R, 42011

    Distribution

    US distribution in states of: CO, DC, MA and TX.

    Quantity

    11 caddies