ConForMIS iDuo Knee Replacement Recalled for Ethylene Glycol Residue
ConforMIS, Inc. is recalling 12 units of the iDuo Knee Bicompartmental 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 12 units of the ConForMIS iDuo Knee Bicompartmental Knee Replacement System, specifically the iDUO G2, Right Medial model. The recall is being conducted 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 United Kingdom. The specific catalog numbers involved are M57230600220 (US) and M5723INT0600220 (OUS). Specific serial numbers for the US and other regions are listed in the official recall documentation.
Consumers and healthcare providers should check their inventory for these specific serial numbers. If the product is found, it should be removed from use and returned to the manufacturer or the appropriate regulatory authority as directed by ConforMIS, Inc.
The recalled product
- Product
- ConForMIS iDuo Knee Bicompartmental Knee Replacement System , iDUO G2, Right Medial Catalog Number: M57230600220 (US) M5723INT0600220 (OUS)
- Manufacturer
- ConforMIS, Inc.
- Hazard
- Affected units
- 12
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 Numbers (US): 0354902
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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