BEUDAMED
    FDA Enforcement Class II Terminated

    12 mm Distraction Pin, Blunt Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation screw utilized during cervical spine procedures.

    Recall: Z-2107-2017 · Reported May 24, 2017

    Enforcement

    Recall Number
    Z-2107-2017
    Event ID
    76298
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES INC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 24, 2017
    Initiation Date
    December 14, 2016
    Classification Date
    May 17, 2017
    Termination Date
    July 9, 2019
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    12 mm Distraction Pin, Blunt Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation screw utilized during cervical spine procedures.

    Reason

    Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possible that the seal on the sterile packaging has been compromised resulting in a loss of sterility of the medical device contained within.

    Code Info

    Item# MDS9091212B; Lots #136780

    Distribution

    Nationwide Distribution

    Quantity

    300 individual packs