Reported Mar 17, 2021 · Terminated

Thread-like wire marker

Somatex Medical Technologies 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: Somatex Medical Technologies GMBH · Hohenzollerndamm 150-151 · Berlin · N/A

Is this the product you have?

  • Thread-like wire marker
Lot codes and dates

6 of 6 products

Products covered by this recall
Model / numberProduct as published
271640Affected Lots: 51268, 51414
271641Affected Lots: 51269, 51410
271642Affected Lots: 51270, 51411
271650REF 271643 Affected Lots: 51271, 51412. Tuflex Premium: Affected Lots: 51300
271651Affected Lots: 51299, 51413
271652Affected Lots: 51301.
Amount recalled
196 pieces

Where it was sold

Why it was recalled

This recall has been initiated due to the risk of wire splintering after contact with a cautery device during the removal of a lesion. There is a potential risk that wire fragments are not removed during the procedure and stays inside the patient's body.

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 Somatex Medical Technologies 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 13, 2022 · Data as of Sep 19, 5:43 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.