Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall 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.

U.S. FDA — Device Enforcement · United States · 2017-09-01 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0623-2018
Date of alert
2017-09-01
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Aesculap Implant Systems LLC
Product category
device
Product type
Devices
Reported risk: 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).
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.