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.

Due to labeling error. Product incorrectly labeled.

On 05/09/2025, the firm sent via email an "URGENT: Medical Device Field Action Notification" Letter dated 5/5/2025. This letter describes the product, problem and actions to be taken. Customers are instructed to: 1.Retrieve all affected units in storage or distribution and return to Canary Medical at 9315 Winnetka Ave N Suite 300 Brooklyn Park, MN, 55445 Attn: Gina Brownfield 2.Review your sales records and identify if any Affected Product has been distributed to your customers and complete Appendix 1 form Notification to Customers in the Medical Device Recall Response Form attached. Sign the completed Medical Device Recall Response Form return it via [email protected] or fax to 574-373-3589 or 574-372-4011. For questions or assistance - contact Customer Service at: Phone: 1-833-692-2627 Email: [email protected] Mail: Canary Medical USA LLC 2710 Loker Ave. West, Suite 350 Carlsbad, CA 92010 USA