ConFormis iTotal CR Knee Replacement System Recalled for Ethylene Glycol Residue
ConforMIS, Inc. is recalling 3 units of the iTotal CR Knee Replacement System because they may contain small amounts of ethylene glycol residue.
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, and the source text describes the hazard as 'small amounts' of residue without reporting any illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
ConforMIS, Inc. is recalling 3 units of the ConFormis iTotal CR Knee Replacement System, specifically the ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - LEFT and RIGHT (Catalog Number: TCR1111111). The recall is issued because the devices may contain small amounts of ethylene glycol residue.
The affected units were distributed nationwide in the United States, as well as in Germany, Switzerland, and the UK. The specific serial numbers for the US units are 0354697, 0353789, and 0354533.
Healthcare providers and patients should contact ConforMIS, Inc. for further instructions regarding the return or replacement of these specific implant kits.
The recalled product
- Product
- ConFormis iTotal CR Knee Replacement System- ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - LEFT ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - RIGHT Catalog Number: TCR1111111
- Manufacturer
- ConforMIS, Inc.
- Hazard
- Affected units
- 3
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 (3)
- Serial Numbers (US): 0354697
- 0353789
- 0354533
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by ConforMIS, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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