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U.S. Department of Health and Human Services

Class 2 Device Recall JPlasma Precise 360

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  Class 2 Device Recall JPlasma Precise 360 see related information
Date Initiated by Firm June 18, 2018
Create Date October 19, 2018
Recall Status1 Terminated 3 on April 08, 2019
Recall Number Z-0198-2019
Recall Event ID 80544
510(K)Number K152570  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product 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.
Code Information Catalog Numbers: BVX-330BR, BVX-330NR, BVX-450BR, BVX-450NR. All lot number are included that have been manufactured since 05/01/2016.
Recalling Firm/
Manufacturer		 Bovie Medical Corporation
5115 Ulmerton Rd
Clearwater FL 33760-4004
For Additional Information Contact Dr. Topaz J. Kirlew, MBA, MT(ASCP)
727-803-8617
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Nonconforming Material/Component
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 corrections@boviemed.com or by fax to the Regulatory Affairs Department at (727) 388-4697. Questions and comments can be directed to corrections@boviemed.com or call toll free 1-800-537-2790, Monday through Friday, 8:00 AM to 5:00 PM, Eastern Time.
Quantity in Commerce 1,176 total units
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = BOVIE MEDICAL CORPORATION
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