BEUDAMED
    FDA Enforcement Class II Ongoing

    Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, disposable ruler, (2) FlexSticks, 30 ml syringe, and (2) 17 Ga Needles. Used to aid the surgeon in establishing arthroscopic portals and joint access.

    Recall: Z-0287-2024 · Reported November 15, 2023

    Enforcement

    Recall Number
    Z-0287-2024
    Event ID
    93140
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 15, 2023
    Initiation Date
    September 13, 2023
    Classification Date
    November 9, 2023
    Address
    5900 Optical Ct, San Jose, CA, 95138-1400, United States

    Description

    Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, disposable ruler, (2) FlexSticks, 30 ml syringe, and (2) 17 Ga Needles. Used to aid the surgeon in establishing arthroscopic portals and joint access.

    Reason

    Expired product distributed

    Code Info

    Lot # 007047/UDI: 07613252632863

    Distribution

    US: NH, TX, NY, NJ, OH, MN OUS: None

    Quantity

    19 kits