# FDA recall Z-0650-2022

> **Merete Medical GmbH** · Class II · device recall initiated 2022-01-18.

## Product

Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only

## Reason for recall

Incorrect marketing label (25 mm) was applied to product size 20 mm.

## Distribution

Domestic: Illinois; Foreign: Germany.

## Key facts

- **Recall number:** Z-0650-2022
- **Recalling firm:** Merete Medical GmbH
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-01-18
- **Report date:** 2022-02-23
- **Termination date:** 2023-02-16

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0650-2022

## Citation

> AI Analytics. FDA recall Z-0650-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0650-2022. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*