BEUDAMED
    FDA Enforcement Class II Terminated

    MicroAire K-Wires

    Recall: Z-1407-2017 · Reported March 15, 2017

    Enforcement

    Recall Number
    Z-1407-2017
    Event ID
    76560
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    MicroAire Surgical Instruments, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 15, 2017
    Initiation Date
    February 21, 2017
    Classification Date
    March 3, 2017
    Termination Date
    July 14, 2017
    Address
    3590 Grand Forks Blvd, N/A, Charlottesville, VA, 22911-9006, United States

    Description

    MicroAire K-Wires

    Reason

    Mislabeling on three lots of K-Wires. The incorrect product description " dual trocar" instead of "single trocar" was on the product label on the following parts: 1600-9355NS (lot 61005), 1600-9625NS (lot 60297), and 1604-162NS (lot 62856).

    Code Info

    Part Number, Lot Number, Quantity Distributed to Field 1600-9355NS, 61005, 56; 1600-9625NS, 60297, 209; 1604-162NS, 62856, 97.

    Distribution

    United States.

    Quantity

    Total 362