Canturio Smart Extension implant components recalled for labeling error
Canary Medical is recalling 106 Canturio® Smart Extension knee implant components due to incorrect labeling. Units were distributed in Indiana.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II labeling error with no reported injuries or illnesses. Labeling errors without documented harm fall under moderate severity per the rubric.
Plain-English summary
Canary Medical, Inc. is recalling 106 units of the Canturio® Smart Extension (CSE) Implant, a tibial stem extension component for use with the Zimmer Persona® Personalized Knee System. The affected product has model number 43-5570-030-14.
The recall was issued due to a labeling error. The product was incorrectly labeled.
The affected units were distributed in the United States to Indiana. The lot numbers involved are AJ327, AJ330, and AJ592. Specific serial numbers for affected units are detailed in the official FDA recall notice.
Healthcare providers and patients who may have received these implants should verify the lot and serial numbers against those listed in the recall. Individuals with questions should contact Canary Medical or consult their healthcare provider for guidance on affected implants.
The recalled product
- 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 fo
- Manufacturer
- Canary Medical, Inc.
- Hazard
- labeling-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- AJ330
Distribution
Distributed in 1 state:
- IN
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