Aesculap Implant Systems LLC recalls ELAN 4 Burr: ELAN 4 1-RING ROSEN BURR+ D0.6 ELAN 4 1-RING ROSEN BURR+ D0.8 ELAN 4 1-RING ROSEN BURR D1.0 ELAN 4 1-RING…

Recall date

September 5, 2017

Source

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

Recall number

Z-0619-2018

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 Burr: ELAN 4 1-RING ROSEN BURR+ D0.6 ELAN 4 1-RING ROSEN BURR+ D0.8 ELAN 4 1-RING ROSEN BURR D1.0 ELAN 4 1-RING ROSEN BURR TC D1.0 ELAN 4 1-RING ROSENBURR+ D1.0 ELAN 4 1-RING ROSEN BURR D1.4 ELAN 4 1-RING ROSENBURR+ D1.4 ELAN 4 1-RING ROSEN BURR D1.8 ELAN 4 1-RING ROSEN BURR+ D1.8 ELAN 4 1-RING ROSEN BURR TC D2.0 ELAN 4 1-RING ROSEN BURR D2.3 ELAN 4 1-RING ROSEN BURR+ D2.3 ELAN 4 1-RING ROSEN BURR D2.7 ELAN 4 1-RING ROSEN BURR+ D2.7 ELAN 4 1-RING ROSEN BURR D3.0 ELAN 4 1-RING ROSEN BURR TC D3.0 ELAN 4 1-RING ROSEN BURR D3.5