FDAApril 20, 2020device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Unexpected stress fractures on the shaft of the hand piece may result in fragmentation during clinical use.
What to do
FDA enforcement status: Terminated
Brands named
bovie medicalbovie
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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