BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X

    Recall: Z-1510-2026 · Reported March 18, 2026

    Enforcement

    Recall Number
    Z-1510-2026
    Event ID
    98376
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Exactech, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 18, 2026
    Initiation Date
    February 3, 2026
    Classification Date
    March 9, 2026
    Address
    2320 Nw 66th Ct, N/A, Gainesville, FL, 32653-1630, United States

    Description

    Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X

    Reason

    Impactor handle may be missing cross-pin

    Code Info

    All Lots/ UDI-DI: 10885862559166

    Distribution

    US: CA CO FL GA HI ID IL IN KS KY LA MA MD ME MN NV NY OH OK PR SC TN TX VA WI OUS: Australia France Germany Italy Japan Korea Spain Switzerland United Kingdom United Arab Emirates Slovenia

    Quantity

    596 kits