BEUDAMED
    FDA Enforcement Class II Ongoing

    MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular and neurological tissues, microsurgery or ophthalmic surgery.

    Recall: Z-0487-2025 · Reported November 27, 2024

    Enforcement

    Recall Number
    Z-0487-2025
    Event ID
    95583
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ETHICON, INC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 27, 2024
    Initiation Date
    October 8, 2024
    Classification Date
    November 19, 2024
    Address
    Calle Durango 2751, Col. Parque Industrial Americas, Juarez, Juarez, N/A, N/A, Mexico

    Description

    MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular and neurological tissues, microsurgery or ophthalmic surgery.

    Reason

    Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.

    Code Info

    Product Number: Y936H UDI-DI code: 10705031059917 Lot Number: TMMDQD

    Distribution

    U.S.: AK, AL, AR, AZ, CA, CO,CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. O.U.S.: Not provided.

    Quantity

    16,524 devices