Class 2 Device Recall Renuvion/JPlasma Precise Open Handpiece

• Date Initiated by Firm: April 20, 2020
• Create Date: May 20, 2020
• Recall Status: Terminated on September 13, 2022
• Recall Number: Z-2060-2020
• Recall Event ID: 85597
• 510(K)Number: K170188 K183610
• Product Classification: Electrosurgical, cutting & coagulation & accessories - Product Code GEI
• Product: Renuvion/ J-Plasma Precise Open Handpiece. Catalog numbers BVX-044-BPS, BVX-044-BPP, BVX-150-BPP, BVX-150-BPS, APYX-044-BPS, APYX-150-BPP, and APYX-150-BPS - Product Usage: for electrosurgical cutting, coagulation and ablation of soft tissue during open surgical procedures.
• Code Information: The following Catalog numbers which were distributed from 06/01/2016 through present: BVX-044-BPS, BVX-044-BPP, BVX-150-BPP, BVX-150-BPS, APYX-044-BPS, APYX-150-BPP, APYX-150-BPS
• Recalling Firm/ Manufacturer: Bovie Medical Corporation; 5115 Ulmerton Rd; Clearwater FL 33760-4004
• For Additional Information Contact: Dr. Topaz J. Kirlew; 1-800-537-2790
• Manufacturer Reason for Recall: Unexpected stress fractures on the shaft of the hand piece may result in fragmentation during clinical use.
• FDA Determined Cause: Under Investigation by firm
• Action: On April 23, 2020 Apyx Medical (Formerly Bovie Medical) sent out an URGENT Medical Device Field Safety Notice identifying the problem, under what circumstances it can occur, the actions that should be taken by the customer/user in order to prevent risk to patients/users, and the actions planned by Apyx Medical to correct the problem. PRODUCTS: All lots of the Renuvion/J-Plasma Precise Hand piece with specified Catlog #'s that are not expired, and all lots of the Renuvion/J-Plasma Precise Open Handpiece with specified Catlog #'s that are not expired. ACTIONS TO BE TAKEN BY CUSTOMER/USER: Follow the cleaning instructions provided in the Instructions for Use (IFU) to remove coagulum/eschar from the blade during clinical use: For optimum performance, keep the distal end of the shaft free of debris. A damp gauze pad can be used for cleaning. Do not activate while cleaning the tip . Follow all specified cleaning instructions identified in the Field Safety Notification which are also in the product Instructions for Use (IFU's). Do Not modify or alter the tip of the device. Do Not use a cannula or a skin port that has tight interference with the outer diameter of the shaft of the device. Discontinue using the hand piece if during clinical use if a stress fracture develops and immediately report to Apyx Medical for return if any devices that exhibit this issue during clinical use. Customers should sign and return the customer response form via email indicating they have read and understand the instructions by May 1st of 2020.
• Quantity in Commerce: 13,948
• Distribution: Worldwide distribution - US nationwide including in the states of Puerto Rico, and the countries of CA, JO, CO, MX, BR, CR, PA, KW, CL, MA, ES, TH, PH, IQ, LB, DO, Japan, QA, AE, PE, AU, VN, IL, Lithuania, UAE, Belgium, Denmark, Austria, Poland, Germany, Slovakia, Spain, Cyprus, Switzerland, Turkey, UK, Italy, Bulgaria, Greece, Norway, Ireland, Hungary, and Croatia.
• 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