Voyant Open Fusion Device recall
Voyant Open Fusion Device Models: EB040 and EB040+ Product Usage: The Applied Voyant Open Fusion Device is designed for use with the Voyant…
Why was Voyant Open Fusion Device recalled?
Potential to improperly characterize tissue within the jaws, which may result in nonoptimal power delivery.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number: EB040 Lot Numbers: 1243964, 1243975, 1244125 Model Number: EB040+ Lot Numbers: 1245512, 1245513, 1246241, 1246508, 1247079, 1247566, 1248102, 1249264
- Product
- Voyant Open Fusion Device Models: EB040 and EB040+ Product Usage: The Applied Voyant Open Fusion Device is designed for use with the Voyant…
- Recalling firm
- Applied Medical Resources Corp
- Quantity
- 101 units (U.S) and 38 units (International)
- Distribution
- Worldwide Distribution - U.S Nationwide in the states of:FL, GA, NV. and countries of: France, Netherlands, Spain, and United Kingdom.
- Recall date
- September 23, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)