BEUDAMED
    FDA Recall Terminated

    MicroAire PAL Cannula Product Usage - Power Aspiration Device

    Recall: Z-1328-2016 · Initiated February 8, 2016

    Recall

    Recall Number
    Z-1328-2016
    Event Number
    73373
    Firm
    MicroAire Surgical Instruments, LLC
    FEI Number
    2020601
    Product Code
    GEA
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 8, 2016
    Terminated
    February 14, 2017
    Address
    3590 Grand Forks Blvd, Charlottesville, VA, 22911-9006

    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.

    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

    Quantity

    145 manufactured and distributed