BEUDAMED
    FDA Enforcement Class II Ongoing

    LinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136.

    Recall: Z-1810-2026 · Reported April 22, 2026

    Enforcement

    Recall Number
    Z-1810-2026
    Event ID
    98594
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Linkbio Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 22, 2026
    Initiation Date
    March 12, 2026
    Classification Date
    April 10, 2026
    Address
    101 Round Hill Dr Ste 7, N/A, Rockaway, NJ, 07866-1214, United States

    Description

    LinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136.

    Reason

    The CORE Workstation may display an incorrect "Planning Date " when viewing cases on the "Start Case" menu screen.

    Code Info

    Product Code: 87-9136. UDI-DI: 00810022403099. All serial numbers of the CORE Workstation are affected.

    Distribution

    US Nationwide distribution in the state of Alabama, Florida, and Kansas.

    Quantity

    5 units