Aesculap ELAN 4 Burr and Blade Accessories Recalled for Regulatory Violation
Aesculap Implant Systems LLC is recalling ELAN 4 burr and blade accessories because they were marketed without 510(k) premarket notification clearance.
What this means for you
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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific hazard is a regulatory violation (lack of 510(k) clearance) rather than a direct physical defect causing injury, aligning with a Moderate severity rating for a voluntary regulatory recall.
Plain-English summary
Aesculap Implant Systems LLC is recalling ELAN 4 burr and blade accessories. The recall was initiated because these medical devices were marketed without 510(k) premarket notification clearance, which is required by the U.S. Food and Drug Administration.
The affected products include various ELAN 4 1-Ring and 2-Ring cutters, saw blades, and diamond discs. The recall covers 6,211 units distributed to four hospitals in New Mexico, Ohio, Texas, and West Virginia. The recall includes all lots of the specified model numbers.
Hospitals and healthcare facilities that have received these products should stop using them and contact Aesculap Implant Systems LLC for further instructions on how to return or dispose of the devices.
The recalled product
- Product
- ELAN 4 Blade: ELAN 4 1-RING PIN CUTTER D1.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D1.5 ELAN 4 1-RING NEURO CUTTER+ SOFT D2.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D2.5 ELAN 4 1-RING NEURO CUTTER SOFT D3.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D3.0 ELAN 4 1-RING NEURO CUTTER D2.0 ELAN 4
- Manufacturer
- Aesculap Implant Systems LLC
- Affected units
- 6,211
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots
Distribution
Part of a larger recall action
This product is one of 3 recalled by Aesculap Implant Systems LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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