BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-2060-2020 · Reported May 27, 2020

    Enforcement

    Recall Number
    Z-2060-2020
    Event ID
    85597
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bovie Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 27, 2020
    Initiation Date
    April 20, 2020
    Classification Date
    May 20, 2020
    Termination Date
    September 13, 2022
    Address
    5115 Ulmerton Rd, N/A, Clearwater, FL, 33760-4004, United States

    Description

    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.

    Reason

    Unexpected stress fractures on the shaft of the hand piece may result in fragmentation during clinical use.

    Code Info

    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

    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.

    Quantity

    13,948