# FDA recall Z-2099-2025

> **Canary Medical, Inc.** · Class II · device recall initiated 2025-05-02.

## Product

Brand Name: Canturio¿ Smart Extension  Product Name: CSE Implant  Model/Catalog Number: 43-5570-030-14  Product Description: Tibial stem extension for use with Zimmer Persona¿ Personalized Knee System; 14mm diameter x 30mm height. Implantable device with integrated electronics for passive kinematic data collection. Single-use, sterile. Packaged in a sterile blister and outer shelf pack. Sold individually.  Component: Yes. The Canturio¿ Smart Extension (CSE) is a tibial implant component intended for use with the Zimmer Persona¿ Personalized Knee System.

## Reason for recall

Due to labeling error.  Product incorrectly labeled.

## Distribution

US Distribution to IN only.

## Key facts

- **Recall number:** Z-2099-2025
- **Recalling firm:** Canary Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-02
- **Report date:** 2025-07-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Carlsbad, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2099-2025

## Citation

> AI Analytics. FDA recall Z-2099-2025. Retrieved 2026-07-11 from https://api.ai-analytics.org/recall/Z-2099-2025. Source: US FDA. Licensed CC0.

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