Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2060-2020 — 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.

U.S. FDA — Device Enforcement · United States · 2020-04-20 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2060-2020
Date of alert
2020-04-20
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Bovie Medical Corporation
Product category
device
Product type
Devices
Reported risk: Unexpected stress fractures on the shaft of the hand piece may result in fragmentation during clinical use.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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