J-Plasma Handpiece, Blade Tip, Pistol Grip, Bovie J-Plasma Precise Open Blade Handpiece Type S & Type P (2020-04-28)
- Starting date:
- April 28, 2020
- Posting date:
- May 15, 2020
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-73103
Last updated: 2020-05-15
Affected Products
- J-Plasma Handpiece, Blade Tip, Pistol Grip
- Bovie J-Plasma Precise Open Blade Handpiece Type S
- Bovie J-Plasma Precise Open Blade Handpiece Type P
Reason
Apyx Medical (formerly Bovie Medical) has recently received four (4) reports of unexpected stress fractures on the shaft of the handpiece resulting in fragmentation during clinical use.
Affected products
A. J-Plasma Handpiece, Blade Tip, Pistol Grip
Lot or serial number
- All lots.
Model or catalog number
- BVX-150B
- BVX-270B
- BVX-330B
Companies
- Manufacturer
-
Bovie Medical Corporation
5115 Ulmerton Road
Clearwater
33760
Florida
UNITED STATES
B. Bovie J-Plasma Precise Open Blade Handpiece Type S
Lot or serial number
- All lots.
Model or catalog number
- BVX-044-BPS
- BVX-150-BPS
Companies
- Manufacturer
-
Bovie Medical Corporation
5115 Ulmerton Road
Clearwater
33760
Florida
UNITED STATES
C. Bovie J-Plasma Precise Open Blade Handpiece Type P
Lot or serial number
- All lots.
Model or catalog number
- BVX-150-BPP
Companies
- Manufacturer
-
Bovie Medical Corporation
5115 Ulmerton Road
Clearwater
33760
Florida
UNITED STATES