Aesculap ELAN 4 Air System Recalled for Premarket Clearance Issues
Aesculap Implant Systems LLC is recalling 167 units of the ELAN 4 Air System because they were released to the market before receiving FDA 510(k) clearance.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text indicates a regulatory compliance issue (release prior to 510(k) clearance) rather than a specific physical defect or reported injury, aligning with the 'Moderate' criteria for voluntary or regulatory recalls without reported harm.
Plain-English summary
Aesculap Implant Systems LLC is recalling 167 units of the ELAN 4 Air System. This medical device is intended for high-speed cutting, sawing, and drilling of bone in spine, ENT, neuro, and maxillofacial surgery. The recall involves specific control and surgical sets, including the ST0607, ST0608, ST0609, ST06411, ST0614, ST0615, and ST0638 models.
The recall was initiated because the devices were released to the marketplace prior to receiving authorized FDA 510(k) clearance. The agency classifies this as a Class II recall. The issue does not affect sales outside the United States.
The devices were distributed nationwide. Healthcare facilities and users should stop using the affected units and contact Aesculap Implant Systems LLC for instructions on return or replacement.
The recalled product
- 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.
- Manufacturer
- Aesculap Implant Systems LLC
- Affected units
- 167
Distribution
Distributed nationwide across the United States.
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