ConForMIS iUNI Knee Replacement Recalled for Ethylene Glycol Residue
ConForMIS is recalling 6 units of the iUNI Unicondylar Knee Replacement System due to potential 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 does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
ConForMIS, Inc. is recalling 6 units of the iUNI Unicondylar Knee Replacement System (iUNI G2, Right Lateral). The recall is issued because the devices may contain small amounts of ethylene glycol residue.
The affected products are identified by specific catalog numbers and serial numbers. The US catalog number is M57220600240, and the international catalog number is M5722INT0600240. The affected US serial numbers are 0353697, 0354749, 0349417, and 0354328. The affected international serial numbers are 0352836 and 0355233.
These devices were distributed nationwide in the United States, as well as in Germany, Switzerland, and the United Kingdom. Healthcare providers and patients should contact ConForMIS, Inc. for further instructions regarding the recall and potential replacement or repair of the devices.
The recalled product
- Product
- ConForMIS iUNI Unicondylar Knee Replacement System iUNI G2, Right Lateral Catalog Number: M57220600240 (US) M5722INT0600240 (OUS)
- Manufacturer
- ConforMIS, Inc.
- Hazard
- Affected units
- 6
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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