The ELAN 4 Air System is intended for high speed recall
The ELAN 4 Air System is intended for high speed cutting, sawing and drilling of bone in fields of Spine, ENT, Neuro, and Maxillofacial Surgery.
Why was The ELAN 4 Air System is intended for high speed recalled?
The ELAN 4 Air System was released to the market place prior to an authorized FDA 510K clearance. This issue does not affected sales outside the United States (OUS).
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?
ELAN 4 Air System ST0607 ELAN 4 Air Control Set ST0608 ELAN 4 Air Neuro Crani Set ST0609 ELAN 4 Air Spine Set ST06411 ELAN 4 Air HD Spine Set ST0614 ELAN 4 Air Micro Saw Set ST0615 ELAN 4 Air Hand Control Set ST0638 ELAN 4 Air Large Saw Set
- Product
- The ELAN 4 Air System is intended for high speed cutting, sawing and drilling of bone in fields of Spine, ENT, Neuro, and Maxillofacial Surgery.
- Recalling firm
- Aesculap Implant Systems LLC
- Quantity
- 167 Units
- Distribution
- Nationwide Distribution.
- Recall date
- February 21, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)