CLASS II Device recall · Reported 17 Mar 2021 · FDA Enforcement Report
Thread-like wire marker recalled by Somatex Medical Technologies
Somatex Medical Technologies is recalling Thread-like wire marker, distributed in New Jersey, Ohio. The recall was initiated on 3 Feb 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1200-2021
- FDA event ID
- 87317
- Recalling firm
- Somatex Medical Technologies, Berlin
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Feb 2021
- FDA classified
- 10 Mar 2021
- Reported
- 17 Mar 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 3 Feb 2021 | Recall initiated by company | |
| 10 Mar 2021 | Classified by FDA | +35 days |
| 17 Mar 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
Thread-like wire marker
Where it was distributed
Domestic: Mo, NJ, OH
Questions about this recall
Is Thread-like wire marker recalled?
Yes. Somatex Medical Technologies recalled Thread-like wire marker on 3 Feb 2021. The recall is Class II and its status is Terminated. Recall number Z-1200-2021.
Why was it 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.
Which lots are affected?
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.
Where was it sold?
Domestic: Mo, NJ, OH
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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