BEUDAMED
    FDA Enforcement Class II Terminated

    MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula

    Recall: Z-1323-2016 · Reported April 13, 2016

    Enforcement

    Recall Number
    Z-1323-2016
    Event ID
    73259
    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
    August 12, 2016
    Address
    3590 Grand Forks Blvd, N/A, Charlottesville, VA, 22911-9006, United States

    Description

    MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula

    Reason

    Complaints that the cannula bent/broke during surgery.

    Code Info

    0913228216, 0414243005, 0215266350, 0415269875, and 0515271334.

    Distribution

    Worldwide Distribution. US nationwide including Puerto Rico, Australia, Bangladesh, Czech Republic, India, Japan, Lebanon, New Zealand, Norway, Singapore, Switzerland, Taiwan, and Turkey.

    Quantity

    37