Class II — Canary Medical, Inc.
| Recalling firm | Canary Medical, Inc. |
|---|---|
| Registered facility | CANARY MEDICAL USA LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Due to labeling error. Product incorrectly labeled. |
| 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. |
| Quantity | 106 |
| Distribution | US Distribution to IN only. |
| Initiated | 2025-05-02 |
| Classified | 2025-07-08 |
| Recall number | Z-2099-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Canary Medical, Inc. (Z-2099-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96894/
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