BEUDAMED
    FDA Recall 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 · Initiated May 11, 2015

    Recall

    Recall Number
    Z-1819-2015
    Event Number
    71262
    Firm
    Orthofix, Inc
    FEI Number
    2183449
    Product Code
    FZX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 11, 2015
    Posted
    June 19, 2015
    Terminated
    February 17, 2016
    Address
    3451 Plano Pkwy, Lewisville, TX, 75056-9453

    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.

    Action

    Orthofix sent an Urgent Medical Device Product Advisory Notification letter dated May 11, 2015, to the affected distributors and hospitals. The consignees were directed to inspect thier inventory and perform checks before surgical use of the drill guides. Customers were instructed to provide a copy of the Product Advisory Notification letter if product was further distributed. Customers with questions were instructed to contact their local Orthofix representative and to for returns they should contact Orthofix customer service representative at 888-298-5700.

    Distribution

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

    Quantity

    36 units