ConForMIS Knee Replacement System Recalled for Ethylene Glycol Residue
ConforMIS, Inc. is recalling 71 units of the ConForMIS Unicondylar Knee Replacement System iUNI G2, Left Medial 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 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 voluntary precautionary recall.
Plain-English summary
ConforMIS, Inc. is recalling 71 units of the ConForMIS Unicondylar Knee Replacement System iUNI G2, Left Medial. The recall was initiated because the devices may contain small amounts of ethylene glycol residue.
The affected products are identified by Catalog Numbers M57220600210 (US) and M5722INT0600210 (OUS). The recall covers specific serial numbers distributed nationwide in the United States, as well as in Germany, Switzerland, and the United Kingdom.
Healthcare providers and patients should check their inventory or medical records for the specific serial numbers listed in the official recall notice. If a patient has received an implant from this recall, they should contact their healthcare provider for further instructions.
The recalled product
- Product
- ConForMIS Unicondylar Knee Replacement System iUNI G2, Left Medial Catalog Number: M57220600210(US) M5722INT0600210 (OUS)
- Manufacturer
- ConforMIS, Inc.
- Hazard
- Affected units
- 71
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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