BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported June 18, 2025

    Enforcement

    Recall Number
    Z-1975-2025
    Event ID
    96868
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MicroAire Surgical Instruments, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 18, 2025
    Initiation Date
    May 7, 2025
    Classification Date
    June 12, 2025
    Address
    3590 Grand Forks Blvd, Charlottesville, VA, 22911-9006, United States

    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.

    Code Info

    Catalog (SKU) Numbers:(1) 83030-1 (single pack), (2) 83030-6 (six pack) and (3) 83030-6-CE (six pack OUS only); UDI-DI: (1) 00847399017246 (single pack), (2&3) 00847399015860 (six pack); Lot Numbers: (1) 104842032025, (2) 104841032025, 104873032025, 104885042025, 104902042025, (3) 104865032025;

    Distribution

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

    Quantity

    1,451 eaches