Aesculap Implant Systems LLC recalls PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU

Recall date

April 16, 2021

Source

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

Recall number

Z-2578-2021

FDA classification

Class II

Brand / firm

Aesculap Implant Systems LLC

Sold / distributed

US Nationwide distribution in the states of FL, MI, NY, TX, WI.

Why it was recalled

Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential delay in surgery

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

What was recalled

PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU