BEUDAMED
    FDA Recall 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 · Initiated June 18, 2018

    Recall

    Recall Number
    Z-0198-2019
    Event Number
    80544
    Firm
    Bovie Medical Corporation
    FEI Number
    3007593903
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 18, 2018
    Terminated
    April 8, 2019
    Address
    5115 Ulmerton Rd, Clearwater, FL, 33760-4004

    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.

    Action

    The firm, Bovie Medical, notified customers regarding the recall on or about 06/18/2018 via a letter entitled "URGENT: MEDICAL DEVICE RECALL". The letter alerted customers to discontinue to use the device with the affected catalog and lot numbers, to return the impacted handpieces to Bovie Medical, to consider using a device which did not contain the defective component, and how to receive a replacement device. Bovie Medical indicated the resolution to this issue will be a manufacturing and/or design change to the affected handpieces. The letter also stated to complete and return the response form included with the letter within ten(10) days by email to [email protected] or by fax to the Regulatory Affairs Department at (727) 388-4697. Questions and comments can be directed to [email protected] or call toll free 1-800-537-2790, Monday through Friday, 8:00 AM to 5:00 PM, Eastern Time.

    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