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Canary Medical, Inc. recalls Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030-14 Product Descript
Recalled July 16, 2025 · FDA recall Z-2099-2025 · Canary Medical
Hazard
Due to labeling error. Product incorrectly labeled. · FDA Class II
Units
106
Sold at
US Distribution to IN only.
Description
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.
Manufacturer(s)
Canary Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →