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 / number Product 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.
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