# FDA recall Z-0435-2021

> **Merete Medical GmbH** · Class II · device recall initiated 2020-09-18.

## Product

OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails

## Reason for recall

Product may be mislabeled.

## Distribution

Product was distributed in US - CA, IL, MD, OH, and NJ

## Key facts

- **Recall number:** Z-0435-2021
- **Recalling firm:** Merete Medical GmbH
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-09-18
- **Report date:** 2020-11-18
- **Termination date:** 2021-05-13

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0435-2021

## Citation

> AI Analytics. FDA recall Z-0435-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0435-2021. Source: US FDA. Licensed CC0.

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