PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: July 16, 2025 Initiated: May 2, 2025 #Z-2099-2025

Product Description

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.

Details

Recalling Firm
Canary Medical, Inc.
Units Affected
106
Distribution
US Distribution to IN only.
Location
Carlsbad, CA

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Canary Medical, Inc.. Units affected: 106.
Why was this product recalled? ▼
Due to labeling error. Product incorrectly labeled.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 16, 2025. Severity: Moderate. Recall number: Z-2099-2025.

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