BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No

    Recall: Z-1426-2026 · Reported February 25, 2026

    Enforcement

    Recall Number
    Z-1426-2026
    Event ID
    98282
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Centinel Spine, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 25, 2026
    Initiation Date
    December 31, 2025
    Classification Date
    February 17, 2026
    Address
    900 Airport Rd Ste 3b, West Chester, PA, 19380-3416, United States

    Description

    Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No

    Reason

    Products were mislabeled as the 6mm product but included the 5 mm product.

    Code Info

    Model Number: PDSL6; UDI-DI 00843193113924; Lot 2025-0776;

    Distribution

    US Nationwide distribution in the states of AL, CA, CO, LA, NY, OR, TN, TX.

    Quantity

    20 units