BEUDAMED
    FDA Enforcement Class II Ongoing

    Signature Laparoscopic Instruments, Bullet Tip Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863030.

    Recall: Z-1897-2025 · Reported June 11, 2025

    Enforcement

    Recall Number
    Z-1897-2025
    Event ID
    96755
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Silex Medical, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 11, 2025
    Initiation Date
    January 9, 2024
    Classification Date
    June 2, 2025
    Address
    24 Robert Porter Rd Ste B, N/A, Southington, CT, 06489-1158, United States

    Description

    Signature Laparoscopic Instruments, Bullet Tip Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863030.

    Reason

    Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.

    Code Info

    Model/REF Number: 5863030. UDI-DI: B33158630300. Lot Number: M28185. Serial Numbers: 0446, 0447, 0448, 0449, 0450, 0451.

    Distribution

    US Nationwide distribution in the states of Florida, North Dakota, Illinois, California, Texas, Virginia, Michigan, Connecticut, Oregon, Iowa, Mississippi, New Jersey, Idaho, West Virginia, Hawaii.

    Quantity

    6 units