Class 2 Device Recall Bovie Precise 360 Handpiece

• Date Initiated by Firm: July 18, 2016
• Create Date: August 25, 2016
• Recall Status: Terminated on December 14, 2016
• Recall Number: Z-2646-2016
• Recall Event ID: 74790
• 510(K)Number: K152570
• Product Classification: Electrosurgical, cutting & coagulation & accessories - Product Code GEI
• Product: BVX-330BR Bovie Precise 360 Handpiece 33cm, blade Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.
• Code Information: Lot 0316D, 0416L, and 0516B.
• Recalling Firm/ Manufacturer: Bovie Medical Corporation; 5115 Ulmerton Rd; Clearwater FL 33760-4004
• For Additional Information Contact: Brian Kunst; 727-803-8617
• Manufacturer Reason for Recall: The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Consignees were notified by written recall notice sent via certified mail or courier on July 18, 2016 to quarantine their inventory of the Precise 360 Handpiece, identify and contact their customers that have received the affected product and provide the a copy of the attached field safety notice. Customers are requested to return affected product, and return all affected product currently in their possession. All customer inventory should be reviewed, discontinue use, and return all Bovie Precise 360 handpieces to: Quality Assurance Department, Bovie Medical Corporation, 5115 Ulmerton Road, Clearwater, Florida 33760, Attn: Precise 360 Recall. Also, please write the authorization number RMA XXXX on the outside of the shipping container and use UPS account number 342562 and return via ground shipping and Fax or email the attached recall return response form to the email or fax indicated on the form as soon as possible and include a copy with the shipment. A completed recall return response form is required even if the customer has no product to return. If you have any questions about this recall or the product affected by the recall, call 727-803-8617.
• Quantity in Commerce: 95
• Distribution: Worldwide Distribution - US Nationwide in the states of: MD, GA, MO and FL and the country of Finland.
• 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