BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0970-2024 · Initiated December 18, 2023

    Recall

    Recall Number
    Z-0970-2024
    Event Number
    93725
    Firm
    Vortex Surgical Inc.
    FEI Number
    3013002167
    Product Code
    HNR
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 18, 2023
    Posted
    February 1, 2024
    Terminated
    April 4, 2024
    Address
    4 Research Park Dr, Ste 124, Saint Charles, MO, 63304-5639

    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.

    Action

    The firm issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 12/18/2023 via email. The notice explained the problem with the device, risk to health associated with its use, and requested the return of all devices.

    Distribution

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

    Quantity

    800 devices