BEUDAMED
    FDA Recall Terminated

    SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014

    Recall: Z-2222-2019 · Initiated June 26, 2019

    Recall

    Recall Number
    Z-2222-2019
    Event Number
    83283
    Firm
    MicroAire Surgical Instruments, LLC
    FEI Number
    2020601
    Product Code
    HRX
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    June 26, 2019
    Terminated
    April 29, 2020
    Address
    3590 Grand Forks Blvd, Charlottesville, VA, 22911-9006

    Description

    SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece), part numbers 81014 and 83014

    Reason

    There was a higher than normal incidence rate of the blade not retracting when tightening.

    Action

    Urgent Medical Device Recall notification letters were sent to customers on 6/26/19. Additional customers identified later sent letters on 7/17/19. Regardless of the above IFU information, to be on the safe side, MicroAire is performing this recall and asking that you please complete and send back page two of this letter to [email protected] or via fax at 800-648-4309. We will rework the handpiece (by replacing the handpiece head) and return it to you. If you have any questions about this Recall, please contact MicroAire Customer Service at 1-800-722-0822 between the hours of 8:30 AM and 5:00 PM (EST) Monday through Friday.

    Distribution

    The products were distributed to the following US states: CA, CT, FL, GA, IA, IL, IN, MD, MI, MN, MS, MT, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY. The products were distributed to the following foreign countries: Australia, Czech Republic, France, Germany, and Taiwan.

    Quantity

    103