BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1897-2025 · Initiated January 9, 2024

    Recall

    Recall Number
    Z-1897-2025
    Event Number
    96755
    Firm
    Silex Medical, LLC
    FEI Number
    3005110411
    Product Code
    GEI
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    January 9, 2024
    Posted
    June 2, 2025
    Address
    24 Robert Porter Rd, Ste B, Southington, CT, 06489-1158

    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.

    Action

    Silex formally notified customers on 01/09/2024. Instructions to consignees included to inspect all instruments that they received from the affected lots for the defect. If any instruments had the issue, the customers were instructed to send it back to their facility under an RGA.

    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