ConForMIS iUni Knee Replacement System Recalled for Ethylene Glycol Residue
ConForMIS is recalling 7 units of the iUni Unicondylar Knee Replacement System due to potential 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device with a chemical contamination hazard (ethylene glycol) where no specific injuries or illnesses are reported in the source text, fitting the criteria for a risk-of-harm product without reported injury.
Plain-English summary
ConforMIS, Inc. is recalling 7 units of the ConForMIS iUni Unicondylar Knee Replacement System, specifically the iUNI G2, Left Lateral model. The recall is being conducted because the devices may contain small amounts of ethylene glycol residue.
The affected units are identified by specific catalog and serial numbers. US units have catalog number M57220600230 and serial numbers 0355239, 0355108, 0355474, and 0354538. Units distributed outside the US have catalog number M5722INT0600230 and serial numbers 0353919, 0354845, and 0354849.
The products were distributed nationwide in the United States as well as in Germany, Switzerland, and the United Kingdom. The source text does not specify instructions for consumers or healthcare providers regarding the next steps for these specific units.
The recalled product
- Product
- ConForMIS iUni Unicondylar Knee Replacement System: iUNI G2, Left Lateral Catalog Number: M57220600230 (US) M5722INT0600230 (OUS)
- Manufacturer
- ConforMIS, Inc.
- Affected units
- 7
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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