Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0619-2018·Announced 2018-02-21

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.

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, 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
Category: Medical Device — Surgical Instruments
Hazard: regulatory-non-compliance
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

Distributed in 4 states:

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.

See all 3 products in this recall →

Same manufacturer · Aesculap Implant Systems LLC

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