Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The ELAN 4 Air System is intended for high speed cutting Recalled by Aesculap Implant Systems LLC Due to The ELAN 4 Air System was released to...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Aesculap Implant Systems LLC directly.
Affected Products
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.
Quantity: 167 Units
Why Was This 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).
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Aesculap Implant Systems LLC
Aesculap Implant Systems LLC has 61 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report