FDA recall Z-0198-2019

Bovie Medical Corporation · Class II · device

Product

J-Plasma Precise 360, single use, disposable. The Bovie J-Plasma Precise 360 Handpiece is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparascopic surgical procedures.

Reason for recall

There is a potential risk associated with the PEEK tip of the J-Plasma Precise 360 Handpiece separating from the handpiece and retained in the tissue.

Distribution

Worldwide Distribution: US (nationwide) to states of:: CA, CO, FL, ID, IL, MD, MO, NJ, NY, OH, OR, PA,, TX.; and countries of: Austria, Bahrain, Belgium, Bulgaria, Cyprus, Finland, Great Britain, Hungary, Ireland, Israel, Italy, Qatar, Scandinavia, Slovakia, Switzerland, Turkey, and United Arab Emirates.

Key facts

Status
Terminated
Initiation date
2018-06-18
Report date
2018-10-31
Termination date
2019-04-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Clearwater, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0198-2019