FDA Device recall Z-2099-2025
Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030-14 Product Description: Tibial stem exten…
- FDA Device
- Class II
- ongoing
- Published 2025-07-16
On 2025-07-16 the FDA classified a Class II recall of Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030-14 Product Description: Tibial stem exten… by Canary Medical, citing due to labeling error. Product incorrectly labeled.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2099-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-02 |
| Published | 2025-07-16 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Canary Medical |
| Distribution | IN |
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
Due to labeling error. Product incorrectly labeled.
Identifiers
| code_info | Lot Code: Model No: 43-5570-030-14UDI-DI (GTIN): 00860003118399 Lot Numbers: AJ327, AJ330, AJ592 Serial Numbers: Provi…Lot Code: Model No: 43-5570-030-14UDI-DI (GTIN): 00860003118399 Lot Numbers: AJ327, AJ330, AJ592 Serial Numbers: Provided in Attachment Lot Numbers / CSE Serial Numbers / UDI code: AJ327 30939 (01)00860003118399(17)270228(21)030939 AJ327 30972 (01)00860003118399(17)270228(21)030972 AJ592 31048 (01)00860003118399(17)270228(21)031048 AJ592 31050 (01)00860003118399(17)270228(21)031050 AJ592 31053 (01)00860003118399(17)270228(21)031053 AJ592 31064 (01)00860003118399(17)270228(21)031064 AJ592 31083 (01)00860003118399(17)270228(21)031083 AJ592 31088 (01)00860003118399(17)270228(21)031088 AJ592 31090 (01)00860003118399(17)270228(21)031090 AJ592 31093 (01)00860003118399(17)270228(21)031093 AJ592 31095 (01)00860003118399(17)270228(21)031095 AJ592 31096 (01)00860003118399(17)270228(21)031096 AJ592 31098 (01)00860003118399(17)270228(21)031098 AJ592 31102 (01)00860003118399(17)270228(21)031102 AJ592 31104 (01)00860003118399(17)270228(21)031104 AJ592 31120 (01)00860003118399(17)270228(21)031120 AJ |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2099-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.