Brand Name: Canturio Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030-14 Product Description:
FDA device recall Z-2099-2025 · posted 2025-07-08 · Open, Classified
Recall details
- Recalling firm
- Canary Medical, Inc.
- Reason for recall
- Due to labeling error. Product incorrectly labeled.
- Action taken
- 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 coroorateQuality.PostMarket@zimmerbiomet.com or fax to 574-373-3589 or 574-372-4011. For questions or assistance - contact Customer Service at: Phone: 1-833-692-2627 Email: support@canarymedical.com Mail: Canary Medical USA LLC 2710 Loker Ave. West, Suite 350 Carlsbad, CA 92010 USA
- Root cause
- Process change control
- Status
- Open, Classified
- Product code
- QPP
- Quantity affected
- 106
- Distribution
- US Distribution to IN only.
- Date initiated
- 2025-05-02
- Date posted
- 2025-07-08
- Location
- Carlsbad, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| canturio® se (Canturio Smart Extension) (K234056) | Canary Medical USA, LLC | 2024-04-24 |