FDA Device recall Z-1200-2021
Thread-like wire marker
- FDA Device
- Class II
- terminated
- Published 2021-03-17
On 2021-03-17 the FDA classified a Class II recall of Thread-like wire marker by Somatex Medical Technologies, citing 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 fragment….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1200-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-02-03 |
| Published | 2021-03-17 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Somatex Medical Technologies |
| Distribution | NJ, OH |
Product
Thread-like wire marker
Reason
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.
Identifiers
| code_info | Tuflex: REF 271640 Affected Lots: 51268, 51414; REF 271641 Affected Lots: 51269, 51410; REF 271642 Affected Lots: 51270…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1200-2021%22
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