Aesculap Implant Systems LLC recalls 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…

Recall date

September 5, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0620-2018

FDA classification

Class II

Brand / firm

Aesculap Implant Systems LLC

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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