Reported Jul 16, 2025 · Ongoing

Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030-14 Product…

Canary Medical, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Canary Medical, Inc. · 2710 Loker Ave W Ste 350 · Carlsbad, CA · 92010-6645

Is this the product you have?

  • Brand NameCanturio¿
  • Smart Extension Product NameCSE
  • Implant Model/Catalog Number43-5570-030-14
  • Product DescriptionTibial 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
  • ComponentYes. The Canturio¿ Smart Extension (CSE) is a tibial implant component intended for use with the Zimmer Persona¿ Personalized Knee System
Lot codes and dates
  • Lot CodeModel
  • No43-5570-030-14UDI-DI (GTIN): 00860003118399
  • Lot Numbers
    • AJ327
    • AJ330
  • AJ592 Serial NumbersProvided in Attachment Lot
  • Numbers / CSE Serial Numbers / UDI codeAJ327 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)031953 AJ330 30873 (01)00860003118399(17)270228(21)030873 AJ330 30892 (01)00860003118399(17)270228(21)030892 AJ330 30920 (01)00860003118399(17)270228(21)030920 AJ330 30921 (01)00860003118399(17)270228(21)030921 AJ330 30932 (01)00860003118399(17)270228(21)030932 AJ330 30949 (01)00860003118399(17)270228(21)030949 AJ330 30966 (01)00860003118399(17)270228(21)030966 AJ330 30984 (01)00860003118399(17)270228(21)030984 AJ330 31018 (01)00860003118399(17)270228(21)031018 AJ330 31028 (01)00860003118399(17)270228(21)031028 AJ330 31041 (01)00860003118399(17)270228(21)031041 AJ330 31114 (01)00860003118399(17)270228(21)031114 AJ330 31122 (01)00860003118399(17)270228(21)031122 AJ330 31152 (01)00860003118399(17)270228(21)031152 AJ330 31161 (01)00860003118399(17)270228(21)031161 AJ330 31171 (01)00860003118399(17)270228(21)031171 AJ330 31182 (01)00860003118399(17)270228(21)031182 AJ330 31195 (01)00860003118399(17)270228(21)031195 AJ330 31197 (01)00860003118399(17)270228(21)031197 AJ330 31198 (01)00860003118399(17)270228(21)031198 AJ330 31209 (01)00860003118399(17)270228(21)031209 AJ330 31216 (01)00860003118399(17)270228(21)031216 AJ330 31258 (01)00860003118399(17)270228(21)031258 AJ330 31269 (01)00860003118399(17)270228(21)031269 AJ330 31327 (01)00860003118399(17)270228(21)031327 AJ330 31355 (01)00860003118399(17)270228(21)031355 AJ330 31371 (01)00860003118399(17)270228(21)031371 AJ330 31376 (01)00860003118399(17)270228(21)031376 AJ330 31440 (01)00860003118399(17)270228(21)031440 AJ330 31819 (01)00860003118399(17)270228(21)031819 AJ330 31862 (01)00860003118399(17)270228(21)031862
Amount recalled
106

Where it was sold

Why it was recalled

Due to labeling error. Product incorrectly labeled.

This product could cause temporary or reversible health problems — stop using it.

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By hazard

Where it was distributed

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:16 PM UTC

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