Canary Medical, Inc. recalls Brand Name: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catalog Number:…
Reason for recall
Due to labeling error. Product incorrectly labeled.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
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.
Lot / code information
- Lot #
- Code:
- Model
- 43-5570-030-14
- GTIN
- ): 00860003118399
- Lot #
- AJ327, AJ330, AJ592
- Serial #
- Provided in Attachment
- Lot #
- CSE
- 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(…Show all
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)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
What the firm is doing
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
DistributionShow detailsHide
US Distribution to IN only.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2099-2025
- FDA 510(k) clearance · K234056The device's official FDA premarket clearance record
- FDA device classification · QPPOfficial FDA classification for this device type
- CFR regulation · 21 CFR 888.3600The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Canary Medical, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
More Class II recalls
Zimmer Surgical Inc recalls Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems S…
Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find anot…
- Pneumatic Tourniquet
- Under Investigation by firm
Zimmer Surgical Inc recalls Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems D…
Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find anot…
- Pneumatic Tourniquet
- Under Investigation by firm
W L Gore & Associates, Inc. recalls GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Re…
Due to catheter separation
- Aortic Aneurysm Treatment Endovascular Graft System
- Under Investigation by firm