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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
Recalled February 21, 2018 · FDA recall Z-0620-2018 · Aesculap Implant Systems
Hazard
ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance. · FDA Class II
Units
6211
Sold at
Distributed to 4 hospitals in the following states: NM, OH, TX, WV
Description
ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance.
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
Manufacturer(s)
Aesculap Implant Systems LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →