Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant… — Class II medical device recall Z-2099-2025
Ongoing recall by Canary Medical, Inc., reported 2025-07-16. Due to labeling error. Product incorrectly labeled.
| Recall number | Z-2099-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Canary Medical, Inc., Carlsbad, CA, United States |
| Recall initiated | 2025-05-02 |
| Classified | 2025-07-08 |
| Reported by FDA | 2025-07-16 |
| Quantity | 106 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00860003118399 |
| Lot numbers | AJ327, AJ330, AJ592 |
| Model numbers | 43-5570-030-14, 43-5570-030-14UDI-DI |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2099-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.