BEUDAMED
    FDA Recall Terminated

    Pneumatic Impactor, General Surgery, With Microaire Hose Connector Professional Use, Medical Industry

    Recall: Z-1834-2016 · Initiated March 11, 2016

    Recall

    Recall Number
    Z-1834-2016
    Event Number
    73661
    Firm
    MicroAire Surgical Instruments, LLC
    FEI Number
    2020601
    Product Code
    GET
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 11, 2016
    Posted
    May 27, 2016
    Terminated
    February 14, 2017
    Address
    3590 Grand Forks Blvd, Charlottesville, VA, 22911-9006

    Description

    Pneumatic Impactor, General Surgery, With Microaire Hose Connector Professional Use, Medical Industry

    Reason

    MicroAire discovered that 20 suspect Impactor instruments ( MicroAire Pneumatic Impactor) were shipped to end users and were missing the lock and unlock symbol markings on them.

    Action

    MicroAire sent an Urgent Medical Device Recall letter dated March 28, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. We request that you please respond to this letter promptly to determine how many of these units you have and will be returning to MicroAire. Upon return of the instrument to MicroAire, MicroAire will provide you with replacements. Please complete and send back to MicroAire page two of this letter, indicating that you do have this instrument at your facility and whether you will be returning the instrument for replacement. You can email the form to MicroAire Customer Service at [email protected] or fax the form to 1-800-648-4309. You can contact MicroAire Customer Service at 1-800-722-0822 in the United States or 1-434-975-8000 outside the United States, between the hours of 8:30 AM and 5:30 PM (ET) Monday through Friday if you have any questions.

    Distribution

    United States

    Quantity

    20 units