Canary Medical, Inc.: Device Recall
Recall #Z-2099-2025 · 05/02/2025
Class II: Risk
Recall Details
- Recall Number
- Z-2099-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Canary Medical, Inc.
- Status
- Ongoing
- Date Initiated
- 05/02/2025
- Location
- Carlsbad, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 106
Reason for Recall
Due to labeling error. Product incorrectly labeled.
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.
Distribution Pattern
US Distribution to IN only.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.