BEUDAMED
    FDA Enforcement Class II Terminated

    MicroAire PAL¿ Cannula Product Usage - Power Aspiration Device

    Recall: Z-1328-2016 · Reported April 13, 2016

    Enforcement

    Recall Number
    Z-1328-2016
    Event ID
    73373
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    MicroAire Surgical Instruments, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 13, 2016
    Initiation Date
    February 8, 2016
    Classification Date
    April 5, 2016
    Termination Date
    February 14, 2017
    Address
    3590 Grand Forks Blvd, N/A, Charlottesville, VA, 22911-9006, United States

    Description

    MicroAire PAL¿ Cannula Product Usage - Power Aspiration Device

    Reason

    MicroAire has initiated a recall on product PAL-R4011XL (40cm x 4mm Del Vecchio French Rasp cannula), due to our receipt of three (3) complaints that it bent or broke during surgery. Accordingly, the PAL-R4011XL has also been put on production hold until further notice.

    Code Info

    Include lot numbers/serial numbers 0913228216, 0414243005, 0215266350, 0415269875, 0515271334

    Distribution

    Worldwide Distribution - US Nationwide

    Quantity

    145 manufactured and distributed