BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated August 15, 2025

    Recall

    Recall Number
    Z-2605-2025
    Event Number
    97471
    Firm
    ETHICON, LLC
    FEI Number
    3007791599
    Product Code
    NEW
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    August 15, 2025
    Posted
    September 19, 2025
    Address
    475 Calle C, Ste 401, Guaynabo, PR, 00969-4292

    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.

    Action

    On August 15, 2025, Ethicon, LLC issued an " Urgent Medical Device Recall (Removal)" Notification. Ethicon asked consignees to take the following actions: 1. Examine stock and quarantine affected product. 2. Share notification with all personnel. 3. Complete the response form and and fax 888-202-5865 or email [email protected] 4. Return all unused product. 5. Keep this notice visibly posed for awareness. 6. If assistance is needed, please contact Sedgwick at 888-266-7913 and reference Event # 7924.

    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