BEUDAMED
    FDA Enforcement Class II Ongoing

    Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H

    Recall: Z-0319-2025 · Reported November 13, 2024

    Enforcement

    Recall Number
    Z-0319-2025
    Event ID
    95516
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Ethicon, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 13, 2024
    Initiation Date
    September 25, 2024
    Classification Date
    November 7, 2024
    Address
    1000 Route 202, N/A, Raritan, NJ, 08869-1425, United States

    Description

    Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H

    Reason

    Complaints were received regarding needle pull-off and suture degradation. Analysis on returned product from this lot confirmed that some sutures were visually degraded in the package.

    Code Info

    UDI-DI: 10705031237308 (each); 30705031237302 (box); Lot Number: QP2AJM

    Distribution

    International distribution to the country of China.

    Quantity

    31,032 units