BEUDAMED
    FDA Recall Terminated

    Smith & Nephew ACUFEX TRUNAV Retrograde Drill 11MM Product Number: 72204048 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone

    Recall: Z-1849-2017 · Initiated March 15, 2017

    Recall

    Recall Number
    Z-1849-2017
    Event Number
    76824
    Firm
    Smith & Nephew, Inc.
    FEI Number
    1219602
    Product Code
    GFG
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 15, 2017
    Terminated
    July 10, 2018
    Address
    130 & 120 Forbes Blvd, Mansfield, MA, 02048

    Description

    Smith & Nephew ACUFEX TRUNAV Retrograde Drill 11MM Product Number: 72204048 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

    Action

    Smith &n Nephew sent an Urgent Medical Device Recall Notice dated March 15, 2017, to all affected customers via Federal Express. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return product and to follow instructions on the attached Response Form. Customers with questions were instructed to email [email protected]. For questions regarding this recall call 508-261-3600.

    Distribution

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