FDAFDA · Food and drugs·Recall number Z-2099-2025
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.
Published July 16, 2025 · Recall initiated: May 2, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to labeling error. Product incorrectly labeled.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Canary Medical, Inc.
- Distributor
- US Distribution to IN only.
- Lot
- 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 AJ592 31121 (01)00860003118399(17)270228(21)031121 AJ592 31129 (01)00860003118399(17)270228(21)031129 AJ592 31168 (01)00860003118399(17)270228(21)031168 AJ592 31277 (01)00860003118399(17)270228(21)031277 AJ592 31370 (01)00860003118399(17)270228(21)031370 AJ592 31412 (01)00860003118399(17)270228(21)031412 AJ592 31415 (01)00860003118399(17)270228(21)031415 AJ592 31429 (01)00860003118399(17)270228(21)031429 AJ592 31439 (01)00860003118399(17)270228(21)031439 AJ592 31449 (01)00860003118399(17)270228(21)031449 AJ592 31470 (01)00860003118399(17)270228(21)031470 AJ592 31474 (01)00860003118399(17)270228(21)031474 AJ592 31482 (01)00860003118399(17)270228(21)031482 AJ592 31489 (01)00860003118399(17)270228(21)031489 AJ592 31493 (01)00860003118399(17)270228(21)031493 AJ592 31498 (01)00860003118399(17)270228(21)031498 AJ592 31515 (01)00860003118399(17)270228(21)031515 AJ592 31517 (01)00860003118399(17)270228(21)031517 AJ592 31529 (01)00860003118399(17)270228(21)031529 AJ592 31530 (01)00860003118399(17)270228(21)031530 AJ592 31531 (01)00860003118399(17)270228(21)031531 AJ592 31534 (01)00860003118399(17)270228(21)031534 AJ592 31540 (01)00860003118399(17)270228(21)031540 AJ592 31542 (01)00860003118399(17)270228(21)031542 AJ592 31552 (01)00860003118399(17)270228(21)031552 AJ592 31554 (01)00860003118399(17)270228(21)031554 AJ592 31558 (01)00860003118399(17)270228(21)031558 AJ592 31560 (01)00860003118399(17)270228(21)031560 AJ592 31564 (01)00860003118399(17)270228(21)031564 AJ592 31569 (01)00860003118399(17)270228(21)031569 AJ592 31573 (01)00860003118399(17)270228(21)031573 AJ592 31574 (01)00860003118399(17)270228(21)031574 AJ592 31593 (01)00860003118399(17)270228(21)031593 AJ592 31598 (01)00860003118399(17)270228(21)031598 AJ592 31599 (01)00860003118399(17)270228(21)031599 AJ592 31607 (01)00860003118399(17)270228(21)031607 AJ592 31613 (01)00860003118399(17)270228(21)031613 AJ592 31620 (01)00860003118399(17)270228(21)031620 AJ592 31641 (01)00860003118399(17)270228(21)031641 AJ592 31645 (01)00860003118399(17)270228(21)031645 AJ592 31649 (01)00860003118399(17)270228(21)031649 AJ592 31662 (01)00860003118399(17)270228(21)031662 AJ592 31748 (01)00860003118399(17)270228(21)031748 AJ592 31750 (01)00860003118399(17)270228(21)031750 AJ592 31759 (01)00860003118399(17)270228(21)031759 AJ592 31774 (01)00860003118399(17)270228(21)031774 AJ592 31806 (01)00860003118399(17)270228(21)031806 AJ592 31814 (01)00860003118399(17)270228(21)031814 AJ592 31824 (01)00860003118399(17)270228(21)031824 AJ592 31866 (01)00860003118399(17)270228(21)031866 AJ592 31868 (01)00860003118399(17)270228(21)031868 AJ592 31872 (01)00860003118399(17)270228(21)031872 AJ592 31891 (01)00860003118399(17)270228(21)031891 AJ592 31893 (01)00860003118399(17)270228(21)031893 AJ592 31903 (01)00860003118399(17)270228(21)031903 AJ592 31905 (01)00860003118399(17)270228(21)031905 AJ592 31917 (01)00860003118399(17)270228(21)031917 AJ592 31951 (01)00860003118399(17)270228(21)031951 AJ592 31953 (01)00860003118399(17)270228(21)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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