BEUDAMED
    FDA Recall Terminated

    MicroAire K-Wires

    Recall: Z-1407-2017 · Initiated February 21, 2017

    Recall

    Recall Number
    Z-1407-2017
    Event Number
    76560
    Firm
    MicroAire Surgical Instruments, LLC
    FEI Number
    2020601
    Product Code
    HTY
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    February 21, 2017
    Posted
    March 3, 2017
    Terminated
    July 14, 2017
    Address
    3590 Grand Forks Blvd, Charlottesville, VA, 22911-9006

    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).

    Action

    The firm will mail recall letters to the customers who received the mislabeled k-wires on February 21, 2017. Letters will be sent by UPS to expedite the delivery. The firm will contact the non-responding accounts at least two more times.

    Distribution

    United States.

    Quantity

    Total 362