FDA-Device2018-02-21Class II

ELAN 4 Blade: ELAN 4 1-RING PIN CUTTER D1.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D1.5 ELAN 4 1-RING NEURO CUTTER+ SOFT D2.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D2.5 ELAN 4 1-RING NEURO CUTTER SOFT D3.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D3.0 ELAN 4 1-RING NEURO CUTTER D2.0 ELAN 4 1-RING NEURO CUTTER D2.5 ELAN 4 1-RING NEURO CUTTER D3.0 ELAN 4 1-RING NEURO CUTTER TC D3.0 ELAN 4 1-RING NEURO CUTTER DIAM.D1.5 ELAN 4 1-RING NEURO CUTTER+ DIAM.D1.5 ELAN 4 1-RING NEURO CUTTER DIAM.D2.0 ELAN 4

Aesculap Implant Systems LLC

Hazard

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

Sold states

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

Affected count

6211

Manufactured in

3773 Corporate Pkwy, Center Valley, PA, United States

Products

ELAN 4 Blade: ELAN 4 1-RING PIN CUTTER D1.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D1.5 ELAN 4 1-RING NEURO CUTTER+ SOFT D2.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D2.5 ELAN 4 1-RING NEURO CUTTER SOFT D3.0 ELAN 4 1-RING NEURO CUTTER+ SOFT D3.0 ELAN 4 1-RING NEURO CUTTER D2.0 ELAN 4 1-RING NEURO CUTTER D2.5 ELAN 4 1-RING NEURO CUTTER D3.0 ELAN 4 1-RING NEURO CUTTER TC D3.0 ELAN 4 1-RING NEURO CUTTER DIAM.D1.5 ELAN 4 1-RING NEURO CUTTER+ DIAM.D1.5 ELAN 4 1-RING NEURO CUTTER DIAM.D2.0 ELAN 4 1-RING NEURO CUTTER+ DIAM.D2.0 ELAN 4 1-RING NEURO CUTTER DIAM.D2.5 ELAN 4 1-RING NEURO CUTTER+ DIAM.D2.5 ELAN 4 1-RING NEURO CUTTER DIAM.D3.0 ELAN 4 1-RING NEURO CUTTER+ DIAM.D3.0 ELAN 4 1-RING NEURO CUTTER DIAM.D4.0 ELAN 4 1-RING NEURO CUTTER+ DIAM.D4.0 ELAN 4 2-RING CRANIOTOME CUTTER PAED ELAN 4 2-RING CRANIOTOME CUTTER STANDARD ELAN 4 2-RING CRANIOTOME CUTTER LONG ELAN 4 2-RING CRANIOTOME CUTTER PAED ELAN 4 2-RING CRANIOTOME CUTTER STANDARD ELAN 4 2-RING CRANIOTOME CUTTER LONG ELAN 4 2-RING NEURO CUTTER SOFT D2,0 ELAN 4 2-RING NEURO CUTTER SOFT D2,5 ELAN 4 2-RING NEURO CUTTER SOFT D3,0 ELAN 4 2-RING NEURO CUTTER+ SOFT D3,0 ELAN 4 2-RING NEURO CUTTER SOFT D3,0 ELAN 4 2-RING NEURO CUTTER TC D3,0 ELAN 4 2-RING NEURO CUTTER DIAM. D3,0 ELAN 4 2-RING NEURO CUTTER+ DIAM. D3,0 ELAN 4 2-RING DIAMOND DISC ELAN 4 2-RING SIDE CUTTER TC D3,0 SAW BLADE S sagittal 11/13/0,3 SAW BLADE S sagittal 15/5/0,3 SAW BLADE S sagittal 20/5/0,3 SAW BLADE S sagittal 20/10/0,3 SAW BLADE S sagittal 20/15/0,3 SAW BLADE S sagittal 25/5/0,3 SAW BLADE S sagittal 25/12/0,3 RECIPROCATING SAW BLADE MICRO 13/0.3 RECIPROCATING SAW BLADE MICRO 20/0.3 RECIPROCATING SAW BLADE MICRO 13/0.3 RECIPROCATING SAW BLADE MICRO 20/0.3 ELAN 4 1-RING NEURO CUTTER D1.5+ ELAN 4 1-RING NEURO CUTTER D2.0+ ELAN 4 1-RING NEURO CUTTER D2.5+ ELAN 4 1-RING NEURO CUTTER D3.0+ ELAN 4 1-RING SIDE CUTTING, CARBIDE D2.0 ELAN 4 1-RING NEURO PRECISE D1.5 ELAN 4 1-RING NEURO PRECISE D2.0 ELAN 4 1-RING NEURO PRECISE D2.5 ELAN 4 1-RING NEURO PRECISE D3.0 ELAN 4 2-RING ROUND TIP FISSURE, CARBIDE D0.8 ELAN 4 2-RING ROUND TIP FISSURE, CARBIDE D1.7 ELAN 4 NEURO PRECISE D 1.5

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0621-2018

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