Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catalog Recalled by Canary Medical, Inc. Due to Due to labeling error. Product incorrectly labeled....

Date: May 2, 2025
Company: Canary Medical, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Canary Medical, Inc. directly.

Affected Products

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.

Quantity: 106

Why Was This Recalled?

Due to labeling error. Product incorrectly labeled.

Where Was This Sold?

This product was distributed to 1 state: IN

Affected (1 state)Not affected

About Canary Medical, Inc.

Canary Medical, Inc. has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report