Reported Jul 15, 2020 · Terminated

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

Dufner Instrumente GmbH

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Dufner Instrumente GmbH · Fohrenstr. 9 · Tuttlingen · N/A

Is this the product you have?

  • DUFNER Instrumente GmbH-De Bakey Slim Needleholder- intended to hold a suturing needle for closing wounds during suturing and
  • surgical procedures Reference Number18044-23
Lot codes and dates
  • Lot Numbers8170368 and 8180673
Amount recalled
30 units

Where it was sold

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

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Dufner Instrumente GmbH recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 21, 2021 · Data as of Sep 19, 5:31 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.