CLASS II Device recall · Reported 21 Feb 2018 · FDA Enforcement Report

The ELAN 4 Air System is intended for high speed cutting recalled

Aesculap Implant Systems is recalling The ELAN 4 Air System is intended for high speed cutting, sawing and drilling of bone in, distributed nationwide in the US. The recall was initiated on 1 Sep 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesELAN 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

Quantity recalled167 Units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0623-2018
FDA event ID: 79092
Recalling firm: Aesculap Implant Systems, Center Valley, PA
Classification: Class II
Status: Terminated
Recall initiated: 1 Sep 2017
FDA classified: 15 Feb 2018
Reported: 21 Feb 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Spinal Implants

Timeline

1 Sep 2017	Recall initiated by company
15 Feb 2018	Classified by FDA	+167 days
21 Feb 2018	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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).

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

Nationwide Distribution.

Nationwide

Questions about this recall

Why was it 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 lots are affected?

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

Where was it sold?

Nationwide Distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Aesculap Implant Systems

All 61

Reported	Class	Recall	Company	Reason	Where
13 Sep 2023Device	CLASS II	For intraventricular recalled by Aesculap Implant Systems	Aesculap Implant Systems	Device Malfunction	Nationwide
26 Jul 2023Device	CLASS II	Aesculap Surgical Needle, straight, 3 1/2", width recalled	Aesculap Implant Systems	Packaging Defects	Nationwide
17 May 2023Device	CLASS II	Aesculap Caiman Articulating D5 recalled by Aesculap Implant Systems	Aesculap Implant Systems	Other	Nationwide
3 May 2023Device	CLASS II	Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only recalled	Aesculap Implant Systems	Labeling Errors	Nationwide
7 Sep 2022Device	CLASS II	Aesculap Ennovate Set Screw Sterile-implants are used recalled	Aesculap Implant Systems	Packaging Defects	GA, TX

Other Spinal Implants recalls

All 1,157

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled	Avid Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: ENT recalled	Avid Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: A-P PACK recalled	Avid Medical	Sterility	Nationwide
2 Sep 2026Device	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide