Canturio smart tibial stem extensions recalled over an incorrect product label
Canturio Smart Extension CSE Implants are being recalled due to a labeling error, with the product incorrectly labeled. 106 units are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: FDA Class II recall for a labeling error with no device defect or clinical consequence stated in the source.
Plain-English summary
The Canturio Smart Extension CSE Implant, model number 43-5570-030-14, a tibial stem extension for use with the Zimmer Persona Personalized Knee System measuring 14 mm diameter by 30 mm height, UDI-DI (GTIN) 00860003118399, is being recalled. The action covers 106 units.
The stated reason is a labeling error: the product was incorrectly labeled. The FDA classified the action as Class II. The source does not describe a resulting clinical consequence.
Affected lots include AJ327 and AJ330, together with the further lots listed in the recall notice. Distribution was in Indiana only. The implants are supplied to surgical facilities rather than sold to consumers.
Facilities should identify affected stock using the model number, UDI-DI and lot numbers and follow the instructions issued by the manufacturer.
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…
- Manufacturer
- Canary Medical, Inc.
- Affected units
- 106
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:
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