Z-0623-2018 Class II Terminated
FDA device recall Z-0623-2018 was initiated by Aesculap Implant Systems LLC on September 1, 2017 and is designated Class II. 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). The recall status is terminated (terminated April 3, 2019). Affected quantity: 167 Units.
Recall Details
- Product Type
- Devices
- Report Date
- February 21, 2018
- Initiation Date
- September 1, 2017
- Termination Date
- April 3, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 167 Units
Product Description
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.
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).
Distribution Pattern
Nationwide Distribution.
Code Information
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