Somatex Medical Technologies GMBH Hohenzollerndamm 150-151 Berlin Germany Thread-like wire marker Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Thread-like wire marker
Brand
Somatex Medical Technologies GMBH Hohenzollerndamm 150-151 Berlin Germany
Lot Codes / Batch Numbers
Tuflex: REF 271640 Affected Lots: 51268, 51414, REF 271641 Affected Lots: 51269, 51410, REF 271642 Affected Lots: 51270, 51411, REF 271643 Affected Lots: 51271, 51412. Tuflex Premium: REF 271650 Affected Lots: 51300, REF 271651 Affected Lots: 51299, 51413, REF 271652 Affected Lots: 51301.
Products Sold
Tuflex: REF 271640 Affected Lots: 51268, 51414; REF 271641 Affected Lots: 51269, 51410; REF 271642 Affected Lots: 51270, 51411; REF 271643 Affected Lots: 51271, 51412. Tuflex Premium: REF 271650 Affected Lots: 51300; REF 271651 Affected Lots: 51299, 51413; REF 271652 Affected Lots: 51301.
Somatex Medical Technologies GMBH Hohenzollerndamm 150-151 Berlin Germany is recalling Thread-like wire marker due to 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 pote. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 1/22/2021, Somatex issued an Urgent Medical Device Removal notice to customers via e-mail for Tuflex and Tuflex Premium marking wires. This recall has been initiated due to the risk of wire splintering after contact with a cautery device during the removal of a lesion.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
MO, NJ, OH
Page updated: Jan 10, 2026