BEUDAMED
    FDA Recall Open, Classified

    Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name: ECTR (Endoscopic Carpal Tunnel Release) System, Onyx Blade Assembly; Common Name: SmartRelease Onyx; Catalog (SKU) Numbers: 83030-1 (single pack), 83030-6 (six pack) and 83030-6-CE (six pack OUS only);

    Recall: Z-1975-2025 · Initiated May 7, 2025

    Recall

    Recall Number
    Z-1975-2025
    Event Number
    96868
    Firm
    MicroAire Surgical Instruments, LLC
    FEI Number
    2020601
    Product Code
    EMF
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    May 7, 2025
    Posted
    June 12, 2025
    Address
    3590 Grand Forks Blvd, Charlottesville, VA, 22911-9006

    Description

    Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name: ECTR (Endoscopic Carpal Tunnel Release) System, Onyx Blade Assembly; Common Name: SmartRelease Onyx; Catalog (SKU) Numbers: 83030-1 (single pack), 83030-6 (six pack) and 83030-6-CE (six pack OUS only);

    Reason

    Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.

    Action

    On May 7, 2025 URGENT MEDICAL DEVICE RECALL letters were sent to customers. Specifically, we re asking that you please complete and send back page two of this letter to [email protected] or via fax at 800-648-4309, and to send back your unused product, per the directions. MicroAire will replace these unused units free of charge. 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. We apologize for this inconvenience and are taking the proper steps to ensure that this will not happen in the future.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Denmark, United Kingdom.

    Quantity

    1,451 eaches