Recall Z-0623-2018 ยท HBB Motor, Drill, Pneumatic
Aesculap Implant Systems LLC
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.
| Date | Feb 15, 2018 (initiated Sep 1, 2017) |
| Status | Terminated |
| Reason | 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). |
| 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 |
| Quantity | 167 Units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.