ELAN 4 Drill: ELAN 4 1-RING TWIST DRILL D1 — Class II medical device recall Z-0620-2018
Terminated recall by Aesculap Implant Systems LLC, reported 2018-02-21, distributed in NM, OH, TX, WV. ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.
| Recall number | Z-0620-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aesculap Implant Systems LLC, Center Valley, PA, United States |
| Recall initiated | 2017-09-05 |
| Classified | 2018-02-15 |
| Reported by FDA | 2018-02-21 |
| Terminated | 2019-09-20 |
| Distributed | NM, OH, TX, WV |
| Quantity | 6,211 |
| Model numbers | GP188R, GP189R, GP344R, GP345R, GP346R, GP347R, GP348R, GP349R, US804R, US805R, US806R, US828R, US829R, US830R |
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 TWIST DRILL D2,0 ELAN 4 2-RING WIRE PASS DRILL D1.0 ELAN 4 2-RING WIRE PASS DRILL D1.5 ELAN 4 2-RING WIRE PASS DRILL D2.0 ELAN 4 2-RING WIRE PASS DRILL D1.0 ELAN 4 2-RING WIRE PASS DRILL D1.5 ELAN 4 2-RING WIRE PASS DRILL D2.0
Reason for recall
ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0620-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.