Aesculap Implant Systems LLC recalls For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R

Recall date

July 20, 2023

Source

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

Recall number

Z-2518-2023

FDA classification

Class II

Brand / firm

Aesculap Implant Systems LLC

Sold / distributed

US Nationwide distribution in the states of FL, ID, IL, MD, NC, NY, OR, RI, TX.

Why it was recalled

Trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a result, when used with the 30¿ neuroendoscope, a portion of the visual field is obscured.

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

What was recalled

For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R