The ELAN 4 Air System is intended for high speed cutting, sawing and drilling of bone in fields o...
FDA Device Recall #Z-0623-2018 — Class II — September 1, 2017
Recall Summary
| Recall Number | Z-0623-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 1, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Aesculap Implant Systems LLC |
| Location | Center Valley, PA |
| Product Type | Devices |
| 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.
Lot / 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
Other Recalls from Aesculap Implant Systems LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2518-2023 | Class II | For intraventricular indications mainly used fo... | Jul 20, 2023 |
| Z-2146-2023 | Class II | Aesculap Surgical Needle, straight, 3 1/2", (90... | May 18, 2023 |
| Z-1569-2023 | Class II | Aesculap Caiman Articulating D5/360MM - An elec... | Mar 21, 2023 |
| Z-1430-2023 | Class II | Caspar Cervical Retractor (CCR) Basket ME754 - ... | Feb 23, 2023 |
| Z-1638-2022 | Class II | Aesculap ENNOVATE SET SCREW STERILE-implants ar... | Jul 15, 2022 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.