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-RIN

Recalled February 21, 2018 · FDA recall Z-0619-2018 · Aesculap Implant Systems

Hazard

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

Units

10984

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 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

Manufacturer(s)

Aesculap Implant Systems LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →