# FDA recall Z-1200-2021

> **Somatex Medical Technologies GMBH** · Class II · device recall initiated 2021-02-03.

## 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.

## Distribution

Domestic: Mo, NJ, OH

## Key facts

- **Recall number:** Z-1200-2021
- **Recalling firm:** Somatex Medical Technologies GMBH
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-02-03
- **Report date:** 2021-03-17
- **Termination date:** 2022-01-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Berlin, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1200-2021

## Citation

> AI Analytics. FDA recall Z-1200-2021. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/Z-1200-2021. Source: US FDA. Licensed CC0.

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