FDAFDA · Food and drugs·Recall number Z-0623-2018
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.
Published February 21, 2018 · Recall initiated: September 1, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Aesculap Implant Systems LLC
- Distributor
- Nationwide Distribution.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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