BEUDAMED
    FDA Enforcement Class II Ongoing

    Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.

    Recall: Z-2050-2026 · Reported May 13, 2026

    Enforcement

    Recall Number
    Z-2050-2026
    Event ID
    98721
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Centinel Spine, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 13, 2026
    Initiation Date
    March 20, 2026
    Classification Date
    May 1, 2026
    Address
    900 Airport Rd Ste 3b, West Chester, PA, 19380-3416, United States

    Description

    Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.

    Reason

    Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.

    Code Info

    Model Number: PDSXL5; UDI-DI: 00843193113979; Lot Number: 2026-0026

    Distribution

    US Nationwide distribution in the states of AZ, CA, GA, LA, MO, NY, TN, TX.

    Quantity

    30 units