# FDA recall Z-1184-2024

> **Medagent Inc** · Class II · device recall initiated 2023-12-21.

## Product

Rebstock Holding rod for fixation -For holding and fixation of flexible Leyla Arms and spatula  Art. No. 06-06-285 and 06-06-285MOD.  surgical instrument.

## Reason for recall

Holding arm could move (twist) uncontrollably in the front area. This could lead to a serious deterioration of patient's safety if the movement is transferred to the spatula, which is attached to the holding arm.

## Distribution

TX  Foreign: Algeria China Dominican Republic Germany India Japan Philippines UK

## Key facts

- **Recall number:** Z-1184-2024
- **Recalling firm:** Medagent Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-12-21
- **Report date:** 2024-03-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Portsmouth, NH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1184-2024

## Citation

> AI Analytics. FDA recall Z-1184-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1184-2024. Source: US FDA. Licensed CC0.

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