BEUDAMED
    FDA Enforcement Class II Ongoing

    PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery

    Recall: Z-0480-2023 · Reported December 21, 2022

    Enforcement

    Recall Number
    Z-0480-2023
    Event ID
    91192
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Ethicon, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 21, 2022
    Initiation Date
    November 16, 2022
    Classification Date
    December 14, 2022
    Address
    Us Highway 22 West, N/A, Somerville, NJ, 08876, United States

    Description

    PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery

    Reason

    knot tensile strengths were observed to be significantly below the minimum knot tensile, will result in breakage prior to use or intra-operatively rather than premature post-operative breakage

    Code Info

    UDI-DI: 10705031060623 (individual unit); 30705031060634 (sales unit box) Lot: SCMSHK Exp. Date: February 28, 2027

    Distribution

    International (OUS) only: Canada, Japan, Australia and New Zealand

    Quantity

    7,560 eaches