BEUDAMED
    FDA Enforcement Class II Terminated

    PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.

    Recall: Z-0624-2014 · Reported January 15, 2014

    Enforcement

    Recall Number
    Z-0624-2014
    Event ID
    66273
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    SpineFrontier, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 15, 2014
    Initiation Date
    September 11, 2013
    Classification Date
    January 3, 2014
    Termination Date
    October 8, 2014
    Address
    500 Cummings Ctr Ste 3500, Beverly, MA, 01915-6516, United States

    Description

    PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.

    Reason

    Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect specifications.

    Code Info

    Lot: 012212-001

    Distribution

    US Distribution: including states of: TX and VA.

    Quantity

    13 devices