Aesculap Implant Systems LLC recalls The ELAN 4 Air System is intended for high speed cutting, sawing and drilling of bone in fields of Spine, ENT, Neuro, a…

Recall date

September 1, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0623-2018

FDA classification

Class II

Brand / firm

Aesculap Implant Systems LLC

Sold / distributed

Nationwide Distribution.

Why it was 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).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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.