FDA Medical devices recall ·
Canturio¿ Smart Extension Product Name: CSE Implant Model recall
- Recall number
- Z-2099-2025
- Date
- (initiated May 2, 2025)
- Company / brand
- Canary Medical, Inc.
2710 Loker Ave W Ste 350, Carlsbad, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 106
- Hazard tags
- Mislabeling
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Due to labeling error. Product incorrectly labeled.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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)
Distribution
US Distribution to IN only.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2099-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.