Thread-like wire marker — Class II medical device recall Z-1200-2021
Terminated recall by Somatex Medical Technologies GMBH, reported 2021-03-17, distributed in NJ, OH. This recall has been initiated due to the risk of wire splintering after contact with a cautery device during
| Recall number | Z-1200-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Somatex Medical Technologies GMBH, Berlin, Germany |
| Recall initiated | 2021-02-03 |
| Classified | 2021-03-10 |
| Reported by FDA | 2021-03-17 |
| Terminated | 2022-01-13 |
| Distributed | NJ, OH |
| Quantity | 196 units |
| Lot numbers | 51268, 51269, 51270, 51271, 51299, 51300, 51301, 51410, 51411, 51412, 51413, 51414 |
| Model numbers | 271640, 271641, 271642, 271643, 271650, 271651, 271652 |
Product
Thread-like wire marker
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1200-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.