BEUDAMED
    FDA Enforcement Class II Terminated

    J-Plasma Precise 360, single use, disposable. The Bovie J-Plasma Precise 360 Handpiece is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparascopic surgical procedures.

    Recall: Z-0198-2019 · Reported October 31, 2018

    Enforcement

    Recall Number
    Z-0198-2019
    Event ID
    80544
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bovie Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 31, 2018
    Initiation Date
    June 18, 2018
    Classification Date
    October 19, 2018
    Termination Date
    April 8, 2019
    Address
    5115 Ulmerton Rd, N/A, Clearwater, FL, 33760-4004, United States

    Description

    J-Plasma Precise 360, single use, disposable. The Bovie J-Plasma Precise 360 Handpiece is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparascopic surgical procedures.

    Reason

    There is a potential risk associated with the PEEK tip of the J-Plasma Precise 360 Handpiece separating from the handpiece and retained in the tissue.

    Code Info

    Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NR. All lot number are included that have been manufactured since 05/01/2016.

    Distribution

    Worldwide Distribution: US (nationwide) to states of:: CA, CO, FL, ID, IL, MD, MO, NJ, NY, OH, OR, PA,, TX.; and countries of: Austria, Bahrain, Belgium, Bulgaria, Cyprus, Finland, Great Britain, Hungary, Ireland, Israel, Italy, Qatar, Scandinavia, Slovakia, Switzerland, Turkey, and United Arab Emirates.

    Quantity

    1,176 total units