BEUDAMED
    FDA Enforcement Class II Terminated

    Smith & Nephew ACUFEX TRUNAV Retrograde Drill 11.5MM Product Number: 72204049 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone

    Recall: Z-1850-2017 · Reported April 26, 2017

    Enforcement

    Recall Number
    Z-1850-2017
    Event ID
    76824
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smith & Nephew, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 26, 2017
    Initiation Date
    March 15, 2017
    Classification Date
    April 18, 2017
    Termination Date
    July 10, 2018
    Address
    130 & 120 Forbes Blvd, N/A, Mansfield, MA, 02048, United States

    Description

    Smith & Nephew ACUFEX TRUNAV Retrograde Drill 11.5MM Product Number: 72204049 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone

    Reason

    Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

    Code Info

    Batch Numbers: G11227,G18820

    Distribution

    Worldwide Distribution - US (Nationwide) and Internationally to AU, CL, DB, DE, ES, FR, GB, NL, SE

    Quantity

    N/A