The EPIONE device v1.0.2 is a user controlled recall
The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and manual advancement of one or more…
Why was The EPIONE device v1.0.2 is a user controlled recalled?
Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product number 02-0027) is the subject of rust.
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?
UDI/DI 37603054002NGXL, serial numbers: 0321015 and 0321017
- Product
- The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and manual advancement of one or more…
- Recalling firm
- QUANTUM SURGICAL SAS
- Quantity
- 2 units
- Distribution
- US Nationwide distribution in the state of FL.
- Recall date
- October 16, 2024
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)