BEUDAMED
    FDA Recall Open, Classified

    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.

    Recall: Z-2099-2025 · Initiated May 2, 2025

    Recall

    Recall Number
    Z-2099-2025
    Event Number
    96894
    Firm
    Canary Medical, Inc.
    FEI Number
    3015802419
    Product Code
    QPP
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    May 2, 2025
    Posted
    July 8, 2025
    Address
    2710 Loker Ave W, Ste 350, Carlsbad, CA, 92010-6645

    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.

    Reason

    Due to labeling error. Product incorrectly labeled.

    Action

    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

    Distribution

    US Distribution to IN only.

    Quantity

    106