BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1810-2026 · Initiated March 12, 2026

    Recall

    Recall Number
    Z-1810-2026
    Event Number
    98594
    Firm
    Linkbio Corp.
    FEI Number
    3006721341
    Product Code
    QHE
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 12, 2026
    Posted
    April 10, 2026
    Address
    101 Round Hill Dr, Ste 7, Rockaway, NJ, 07866-1214

    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.

    Action

    LinkBio notified consignees on about 03/12/2026 via email. Consignees were instructed to take note of the potential inaccuracy of the "Planning Date," that no product was required to be returned, and to complete and return the Distributor Reply form. LinkBio Corp. is investigating the root cause of the time/date sync issue and will take appropriate action to ensure accurate dates are displayed for the user.

    Distribution

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

    Quantity

    5 units