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.
Reported: February 21, 2018 Initiated: September 1, 2017 #Z-0623-2018
Product Description
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.
Reason for Recall
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).
Details
- Recalling Firm
- Aesculap Implant Systems LLC
- Units Affected
- 167 Units
- Distribution
- Nationwide Distribution.
- Location
- Center Valley, PA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Aesculap Implant Systems LLC. Units affected: 167 Units.
Why was this product 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).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 21, 2018. Severity: Moderate. Recall number: Z-0623-2018.
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