BEUDAMED
    FDA Enforcement Class II Ongoing

    DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing: 1. DKS Large Obturator Trocar (Model Number 330.017) 2. DKS Large Lighted Cannula (Model Number 330.011) 3. DKS Large Kerrison (330.015) 4. DKS Small Obturator Trocar (330.013) 5. DKs Small Lighted Cannula (330.014) 6. DKS Small Kerrison (330.016)

    Recall: Z-0650-2025 · Reported December 18, 2024

    Enforcement

    Recall Number
    Z-0650-2025
    Event ID
    95476
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Folsom Metal Products, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    December 18, 2024
    Initiation Date
    October 30, 2023
    Classification Date
    December 6, 2024
    Address
    1449 Court Pl, Pelham, AL, 35124-1858, United States

    Description

    DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing: 1. DKS Large Obturator Trocar (Model Number 330.017) 2. DKS Large Lighted Cannula (Model Number 330.011) 3. DKS Large Kerrison (330.015) 4. DKS Small Obturator Trocar (330.013) 5. DKs Small Lighted Cannula (330.014) 6. DKS Small Kerrison (330.016)

    Reason

    Units were not intended for commercial distribution and inadvertently distributed.

    Code Info

    Catalog Number DKS-63030, Lot Numbers: 1560, 1567, 1578. 4 units were not sent to sterilization, therefore were not assigned lot numbers.

    Distribution

    US distribution to KS, LA, MI, NY, TX.

    Quantity

    42 sets