BEUDAMED
    FDA Enforcement Class II Terminated

    ORTHOFIX Centurion POCT System Drill Guide PN 69-1010 and PN 69-1012. Drill Guides are used to interface with various drill tips during the drilling procedure of bone preparation.

    Recall: Z-1819-2015 · Reported July 1, 2015

    Enforcement

    Recall Number
    Z-1819-2015
    Event ID
    71262
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Orthofix, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 1, 2015
    Initiation Date
    May 11, 2015
    Classification Date
    June 22, 2015
    Termination Date
    February 17, 2016
    Address
    3451 Plano Pkwy, Lewisville, TX, 75056-9453, United States

    Description

    ORTHOFIX Centurion POCT System Drill Guide PN 69-1010 and PN 69-1012. Drill Guides are used to interface with various drill tips during the drilling procedure of bone preparation.

    Reason

    There is a possibility that the thumb button remains in the depressed (unlocked) position allowing the threaded sleeve (drill stop) to unintentionally rotate and change the depth setting.

    Code Info

    All lot codes

    Distribution

    Nationwide Distribution including CA, VA, FL, ID, CO, OR, PA, OK, SC, and TX.

    Quantity

    36 units