BEUDAMED
    FDA Enforcement Class II Ongoing

    STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/A MO-4. Product Code: SXPP2B400-11.

    Recall: Z-2605-2025 · Reported October 1, 2025

    Enforcement

    Recall Number
    Z-2605-2025
    Event ID
    97471
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ETHICON, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 1, 2025
    Initiation Date
    August 15, 2025
    Classification Date
    September 19, 2025
    Address
    475 Calle C Ste 401, N/A, Guaynabo, PR, 00969-4292, United States

    Description

    STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/A MO-4. Product Code: SXPP2B400-11.

    Reason

    Potential for barb non-engagement.

    Code Info

    Product Code: SXPP2B400-11. GTIN: 10705031464568 (each), 30705031464562 (box of 12). Lot Number: 104DBB.

    Distribution

    Worldwide - US Nationwide distribution in the states of AR, AZ, CA, IL, IN, KS, MA, MD, MI, MO, MN, NC, NH, NM, TX, VA, WA, WI and the countries of Singapore and Malaysia.

    Quantity

    516 units