Dufner Instrumente GmbH recalls DUFNER Instrumente GmbH-De Bakey Slim Needleholder- intended to hold a suturing needle for closing wounds during suturi…

Recall date

June 3, 2020

Source

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

Recall number

Z-2534-2020

FDA classification

Class II

Brand / firm

Dufner Instrumente GmbH

Sold / distributed

IL

Why it was recalled

Tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure and result in in patient tissue injury

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

What was recalled

DUFNER Instrumente GmbH-De Bakey Slim Needleholder- intended to hold a suturing needle for closing wounds during suturing and surgical procedures Reference Number: 18044-23