Z-0620-2018Class II

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...

Name: Z-0620-2018 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...
Creator: Aesculap Implant Systems LLC
Published: 2017-09-05
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2017-09-05 / Terminated

FDA source

Aesculap Implant Systems LLC began a recall of 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... on 2017-09-05. FDA classified it as Class II and gives the reason as "ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0620-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-05
Posted: 2018-02-15
Terminated: 2019-09-20
Recalling firm: Aesculap Inc
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
Product code: HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Reason for recall: ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.
FDA root cause: No Marketing Application
Action: Notifications were sent requesting the customers immediately discontinue use and quarantine affected products. The notification explains that a sales representative will visit the facilities to remove affected product and return it to the firm.
Quantity in commerce: 6211
Distribution: Distributed to 4 hospitals in the following states: NM, OH, TX, WV
Product codes and lots: All lots, Model Number: GP188R GP189R GP344R GP345R GP346R GP347R GP348R GP349R US804R US805R US806R US828R US829R US830R

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0620-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0619-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-15
Z-0620-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-15
Z-0621-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-21	2018-02-15

Product code HBE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)