Recall Z-0198-2019 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Bovie Medical Corporation
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.
| Date | Jun 18, 2018 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, Bovie Medical, notified customers regarding the recall on or about 06/18/2018 via a letter entitled "URGENT: MEDICAL DEVICE RECALL". The letter alerted customers to discontinue to use the device with the affected catalog and lot numbers, to return the impacted handpieces to Bovie Medical, to consider using a device which did not contain the defective component, and how to receive a replacement device. Bovie Medical indicated the resolution to this issue will be a manufacturing and/or design change to the affected handpieces. The letter also stated to complete and return the res |
| Quantity | 1,176 total units |
| 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 Emi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152570 | Bovie J-Plasma Precise 360 Handpiece Bovie Medical Corporation, Nov 2, 2015 |