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.
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, 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 TWIS
- 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.
See all 3 products in this recall →Related recalls
Same manufacturer · Aesculap Implant Systems LLC
See all →- HighTrocar with oversized shaft obscures surgical view in brain operations
FDA (Devices) · 2023-09-13
- ModerateAesculap Surgical Needle Recalled for Incorrect Product Code Marking
FDA (Devices) · 2023-07-26
- HighAesculap Caiman Articulating Surgical Device Recalled for Loose Spring
FDA (Devices) · 2023-05-17
- ModerateCaspar Cervical Retractor Basket Lids Recalled for Incorrect GTIN Labeling
FDA (Devices) · 2023-05-03
- HighAesculap ENNOVATE Spine Implants Recalled for Incorrect Screw Inclusion
FDA (Devices) · 2022-09-07
Same hazard · regulatory non compliance
See all →- ModerateMedline 10mL Polycarbonate Colored Syringes in Convenience Kits Recalled
FDA (Devices) · 2026-07-01
- ModerateMedline 10mL Polycarbonate Colored Syringes Convenience Kits Recalled
FDA (Devices) · 2026-07-01
- SevereMedline 10mL Polycarbonate Syringes in Medical Procedure Kits Recalled
FDA (Devices) · 2026-07-01
- ModerateMedline Polycarbonate Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- SevereMedline polycarbonate syringes recalled for unapproved design changes
FDA (Devices) · 2026-07-01