BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1834-2016 · Reported June 8, 2016

    Enforcement

    Recall Number
    Z-1834-2016
    Event ID
    73661
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    MicroAire Surgical Instruments, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 8, 2016
    Initiation Date
    March 11, 2016
    Classification Date
    May 27, 2016
    Termination Date
    February 14, 2017
    Address
    3590 Grand Forks Blvd, N/A, Charlottesville, VA, 22911-9006, United States

    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.

    Code Info

    2500-100 Ser#s 1547,1546,1545,1544, 1543,1542, 1541,1540,1539,1538,1537,1536,1535,1534,1533,1532 2500-200 Ser#s 1464,1463,1462,1461

    Distribution

    United States

    Quantity

    20 units