Z-2534-2020Class II

DUFNER Instrumente GmbH-De Bakey Slim Needleholder- intended to hold a suturing needle for closing wounds...

Name: Z-2534-2020 DUFNER Instrumente GmbH-De Bakey Slim Needleholder- intended to hold a suturing needle for closing wounds...
Creator: Dufner Instrumente GmbH
Published: 2020-06-03
License: https://open.fda.gov/license/

Dufner Instrumente GmbH / initiated 2020-06-03 / Terminated / root cause: manufacturing process

FDA source

Dufner Instrumente GmbH began a recall of DUFNER Instrumente GmbH-De Bakey Slim Needleholder- intended to hold a suturing needle for closing wounds during suturing and surgical procedures Reference... on 2020-06-03. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2534-2020
Classification: Class II
Status: Terminated
Initiated: 2020-06-03
Posted: 2020-07-10
Terminated: 2021-01-21
Recalling firm: Dufner Instrumente GmbH
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
Product code: FHQ Holder, Needle, Gastroenterologic
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
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Dufner Instruments GMB issued letter dated June 3, 2020, staing reason for recall, health risk and action to take: 1. Immediately remove all products of the affected article number with the named lots fromyour warehouse or from affected instrument trays to prevent further use. 2. With this letter you will receive a confirmation form, please fill it in completely, sign it and send it back to us after receiving this information. If you do not own any affected products, please fill out the confirmation form anyway and fax it to +49 (0)7461/79419 or mail it to [email protected]. 3. Send back to us immediately all products still in stock. After receipt of the goods we will send you a credit note and clarify with you the further procedure. 4. Pass this information on to all staff in your institution, who should be informed. Please ensure that all users of the affected products within your organization and also all other affected persons receive this information through the Field Safety Notice. If products have been passed on to third parties, please also send them a copy of the Field Safety Notice or inform our contact person to contact the third parties,
Quantity in commerce: 30 units
Distribution: IL
Product codes and lots: Lot Numbers: 8170368 and 8180673

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2534-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2534-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-15	2020-07-07

Product code FHQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)