Z-2060-2020 Class II Terminated
FDA device recall Z-2060-2020 was initiated by Bovie Medical Corporation on Apr 20, 2020 and is designated Class II. Reason for recall: Unexpected stress fractures on the shaft of the hand piece may result in fragmentation during clinical use. The recall status is terminated (terminated Sep 13, 2022). Affected quantity: 13,948.
Recall Details
- Product Type
- Devices
- Report Date
- May 27, 2020
- Initiation Date
- Apr 20, 2020
- Termination Date
- Sep 13, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,948
Product 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 for Recall
Unexpected stress fractures on the shaft of the hand piece may result in fragmentation during clinical use.
Distribution Pattern
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.
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2060-2020
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026