Aesculap ELAN 4 Burr Accessories Recalled for Lack of FDA Clearance
Aesculap Implant Systems LLC is recalling ELAN 4 Burr 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, or where the probability of serious adverse health consequences is remote. The source text identifies the issue as a regulatory compliance failure (lack of 510(k) clearance) rather than a specific 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 accessories, including various 1-Ring Rosen Burr models, because they were marketed without 510(k) premarket notification clearance. The recall involves 10,984 units of these medical device accessories.
The affected products were distributed to four hospitals located in New Mexico, Ohio, Texas, and West Virginia. The recall covers all lots of the specified model numbers.
Hospitals and medical facilities that received these products should stop using them and contact Aesculap Implant Systems LLC for further instructions on the recall process.
The recalled product
- Product
- ELAN 4 Burr: ELAN 4 1-RING ROSEN BURR+ D0.6 ELAN 4 1-RING ROSEN BURR+ D0.8 ELAN 4 1-RING ROSEN BURR D1.0 ELAN 4 1-RING ROSEN BURR TC D1.0 ELAN 4 1-RING ROSENBURR+ D1.0 ELAN 4 1-RING ROSEN BURR D1.4 ELAN 4 1-RING ROSENBURR+ D1.4 ELAN 4 1-RING ROSEN BURR D1.8 ELAN 4 1-RING
- Manufacturer
- Aesculap Implant Systems LLC
- Affected units
- 10,984
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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