FDA-Device2020-07-15Class II
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
Dufner Instrumente GmbH
Hazard
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
Sold states
IL
Affected count
30 units
Manufactured in
Fohrenstr. 9, Tuttlingen, Germany
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2534-2020Don't want to check this manually?
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