BEUDAMED
    FDA Enforcement Class II Ongoing

    ConMed Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.

    Recall: Z-1155-2021 · Reported March 10, 2021

    Enforcement

    Recall Number
    Z-1155-2021
    Event ID
    87274
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Bovie Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 10, 2021
    Initiation Date
    February 1, 2021
    Classification Date
    February 26, 2021
    Address
    5115 Ulmerton Rd, Clearwater, FL, 33760-4004, United States

    Description

    ConMed Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.

    Reason

    There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration.

    Code Info

    Catalog Numbers C3390A (lots 0317F, 0417B, 0517B, 0517D, 0517J, 0617D, 0617F, 0617H, 0617K, 0717A, 0717G, 0817B, 0917G, 0917J, 1017C, 1017E, 1017J, 1117B, 0418C); C3350A (lots 0317F, 0417B, 0517B, 0517G, 0717C, 0817D, 0917C, 0917E); C3350NA (lots 0317F, 0517G, 0817F); C2455NA (lots 0317F, 0517B, 0717E, 1017C, 1017E); C1860NA (lots 0317F, 0517B, 0717E, 0817F, 1017G, 0418E); C3390NA (lots 0317F, 0517G, 0817H, 1017J, 0418E, 0518F, 1218C).

    Distribution

    US Nationwide distribution in the states of CA and FL.

    Quantity

    5270 units