Z-0623-2018Class II

The ELAN 4 Air System is intended for high speed cutting, sawing and drilling of bone in fields of Spine...

Name: Z-0623-2018 The ELAN 4 Air System is intended for high speed cutting, sawing and drilling of bone in fields of Spine...
Creator: Aesculap Implant Systems LLC
Published: 2017-09-01
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2017-09-01 / Terminated

FDA source

Aesculap Implant Systems LLC began a recall of 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 on 2017-09-01. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0623-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-01
Posted: 2018-02-15
Terminated: 2019-04-03
Recalling firm: Aesculap Inc
Product: 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.
Product code: HBB Motor, Drill, Pneumatic
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).
FDA root cause: No Marketing Application
Action: On September 1, 2017 an Urgent Medical Device Recall letter was issued to customers for the ELAN 4 Air System which includes the following sub-components: 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 The letter directs customers to take the following actions: 1. Review the Voluntary Urgent Medical Device Recall Notification Letter in its entirety and ensure that all users in your organization and other concerned persons are informed about this recall and immediately discontinue use. 2. Determine your current inventory of affected products within your facility. Immediately remove the affected products and return to Aesculap Inc. Do not destroy any affected products. 3. Utilizing the attached Product Recall Acknowledgement Response Form on the next page of this letter, record the total number of products in your possession. If you have no inventory remaining, please enter zero (0) on the form and a REASON WHY (example, returned evaluation system to sales representative). 4. Please contact Customer Service and they will provide you with a Returned Goods number and return label. Customer Service: 1-800-282-9000 [email protected]
Quantity in commerce: 167 Units
Distribution: Nationwide Distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0623-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0623-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-15

Product code HBB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)