Conformis iTotal Knee Replacement System Recalled for Incorrect Component
ConforMIS, Inc. is recalling a specific unit of the iTotal Cruciate Retaining Knee Replacement System because an incorrect femoral component was distributed.
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: The recall is classified as FDA Class II, but the source text explicitly states no illnesses or injuries are reported and the hazard is a distribution error (incorrect component) rather than a high-risk pathogen or structural defect causing immediate harm. This aligns with the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls where injury has not been reported.
Plain-English summary
ConforMIS, Inc. is recalling one unit of the Conformis iTotal Cruciate Retaining (CR) Knee Replacement System, Model TCR-111-1111. The recall was initiated because an incorrect femoral component was distributed with the product.
The affected unit is identified by Serial Number 0363410 and UDI M572TCR1111111021/$$316073103634108. The distribution pattern is listed as KY, indicating the product was distributed in Kentucky.
Healthcare providers and patients should check their records for this specific serial number. If the affected unit is in use, providers should contact ConforMIS, Inc. for instructions on replacement or removal. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111
- Manufacturer
- ConforMIS, Inc.
- Hazard
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial Number:0363410 UDI - M572TCR1111111021/$$316073103634108
Distribution
Distributed in 1 state:
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