Z-2649-2016 Class II Terminated
FDA device recall Z-2649-2016 was initiated by Bovie Medical Corporation on Jul 18, 2016 and is designated Class II. Reason for recall: The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip. The recall status is terminated (terminated Dec 14, 2016). Affected quantity: 95.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 31, 2016
- Initiation Date
- Jul 18, 2016
- Termination Date
- Dec 14, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 95
Product Description
BVX-450NR Bovie Precise 360 Handpiece 45cm, needle Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.
Reason for Recall
The adhesive may be inadequately applied or the assembly may be manipulated after application of the adhesive resulting in an incomplete bond to the angled tip.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of: MD, GA, MO and FL and the country of Finland.
Code Information
Lot 0316D.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2649-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026