Recall Z-2060-2020— Bovie Medical Corporation
Class II · Terminated
Class II FDA medical device recall by Bovie Medical Corporation, initiated 2020-04-20, terminated 2022-09-13. It names 2 FDA 510(k) clearances: K183610, K170188. 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.. Reason: Unexpected stress fractures on the shaft of the hand piece may result in fragmentation during clinical use..
- Recalling firm
- Bovie Medical Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-04-20
- Terminated
- 2022-09-13
- Firm location
- Clearwater, FL, United States
510(k) clearances named in this recall
2 on FDA's record- K183610 — Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpieces
- K170188 — Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.