Bovie Medical Corporation recalls Renuvion/ J-Plasma Precise Handpiece. Catalog numbers BVX-150B, BVX-270B, BVX-330B, BVX-270BPP, BVX- 330BPS, APYX-150B

Recalled May 27, 2020 · FDA recall Z-2061-2020 · Bovie Medical

Hazard

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

Units

38,738

Sold at

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.

Description

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

Product

Renuvion/ J-Plasma Precise Handpiece. Catalog numbers BVX-150B, BVX-270B, BVX-330B, BVX-270BPP, BVX- 330BPS, APYX-150B, APYX-270B, APYX-330B, APYX- 270BPP, and APYX-330BPS. Product Usage: for electrosurgical cutting, coagulation and ablation of soft tissue during open and laparoscopic surgical procedures.

Manufacturer(s)

Bovie Medical Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →