BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1323-2016 · Initiated February 8, 2016

    Recall

    Recall Number
    Z-1323-2016
    Event Number
    73259
    Firm
    MicroAire Surgical Instruments, LLC
    FEI Number
    2020601
    Product Code
    BTA
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    February 8, 2016
    Terminated
    August 12, 2016
    Address
    3590 Grand Forks Blvd, Charlottesville, VA, 22911-9006

    Description

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

    Reason

    Complaints that the cannula bent/broke during surgery.

    Action

    The firm is sending letters to all customers who have received PAL-R4011XL from August 2013- October 2015. The firm sent these letters by UPS to expedite the delivery and for traceability.

    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