BEUDAMED
    FDA Enforcement Class II Terminated

    Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25

    Recall: Z-0970-2024 · Reported February 7, 2024

    Enforcement

    Recall Number
    Z-0970-2024
    Event ID
    93725
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Vortex Surgical Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 7, 2024
    Initiation Date
    December 18, 2023
    Classification Date
    February 1, 2024
    Termination Date
    April 4, 2024
    Address
    4 Research Park Dr Ste 124, Saint Charles, MO, 63304-5639, United States

    Description

    Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25

    Reason

    Reason for the voluntary recall is residue was identified on the two forceps tips of a customer in Korea. The residue is associated with one lot of forceps tips which were utilized in two lots of ACTU8 Adaptive Forceps Tips occurring in 0.25% of those lots.

    Code Info

    UDI/DI 00810123481132, Lot Numbers 2212002 and 2212020

    Distribution

    Worldwide - US Nationwide distribution in the states of OH, WA, MN, MI, IA and the country of Republic of Korea

    Quantity

    800 devices