BEUDAMED
    FDA Recall Terminated

    PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.

    Recall: Z-0624-2014 · Initiated September 11, 2013

    Recall

    Recall Number
    Z-0624-2014
    Event Number
    66273
    Firm
    SpineFrontier, Inc.
    FEI Number
    3005977257
    Product Code
    HXB
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    September 11, 2013
    Posted
    January 3, 2014
    Terminated
    October 8, 2014
    Address
    500 Cummings Ctr, Ste 3500, Beverly, MA, 01915-6516

    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.

    Action

    On 9/13/2013, consignees were notified of the recall via email. They were asked to return the recalled product and complete and return the recall acknowledgement form via email or fax.

    Distribution

    US Distribution: including states of: TX and VA.

    Quantity

    13 devices