FDA recall Z-2534-2020

Product

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

Reason for recall

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

Distribution

IL

Key facts

Status

Terminated

Initiation date

2020-06-03

Report date

2020-07-15

Termination date

2021-01-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tuttlingen, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2534-2020