The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0620-2018·Announced 2018-02-21

Aesculap ELAN 4 Drill Accessories Recalled for Lack of FDA Clearance

Aesculap Implant Systems LLC is recalling ELAN 4 drill accessories because they were marketed without required FDA 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, and the source text indicates a regulatory compliance issue (lack of 510(k) clearance) rather than a reported injury or specific physical hazard, aligning with the criteria for moderate severity.

Plain-English summary

Aesculap Implant Systems LLC is recalling specific ELAN 4 drill accessories, including 1-ring and 2-ring twist drills and wire pass drills. The recall involves 6,211 units distributed to four hospitals in New Mexico, Ohio, Texas, and West Virginia.

The recall was initiated because the products were marketed without 510(k) premarket notification clearance, which is required by the FDA for medical devices. The affected model numbers include GP188R, GP189R, GP344R, GP345R, GP346R, GP347R, GP348R, GP349R, US804R, US805R, US806R, US828R, US829R, and US830R.

Hospitals and medical facilities that received these products should stop using them and contact Aesculap Implant Systems LLC for instructions on how to return or dispose of the devices.

The recalled product

Product
ELAN 4 Drill: ELAN 4 1-RING TWIST DRILL D1.5 ELAN 4 1-RING TWIST DRILL D2.0 ELAN 4 2-RING TWIST DRILL D1,0/4,0MM ELAN 4 2-RING TWIST DRILL D1,1/4,0MM ELAN 4 2-RING TWIST DRILL D1,2/4,0MM ELAN 4 2-RING TWIST DRILL D1,5/4,0MM ELAN 4 2-RING TWIST DRILL D1,5 ELAN 4 2-RING…
Manufacturer
Aesculap Implant Systems LLC
Category
Medical Device — Surgical Instruments
Hazard
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

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 →

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