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Recall Observatory FDA recall evidence

Device 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

Z-0620-2018

September 05, 2017

Class II

Product summary

Firm
Aesculap Implant Systems LLC
Event
Event 79068
Status
Terminated
Classification
Class II
Quantity
6211
Official record key
device-enforcement:Z-0620-2018

Official wording

Reason: ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.

Code information: All lots, Model Number: GP188R GP189R GP344R GP345R GP346R GP347R GP348R GP349R US804R US805R US806R US828R US829R US830R

Distribution pattern: Distributed to 4 hospitals in the following states: NM, OH, TX, WV

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.