ConForMIS iUni Knee Replacement Recalled for Ethylene Glycol Residue
ConForMIS is recalling 68 iUni Unicondylar Knee Replacement Systems due to potential small amounts of ethylene glycol residue.
What this means for you
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 medical device with a chemical contamination hazard (ethylene glycol) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' criteria for risk-of-harm products without reported injury.
Plain-English summary
ConForMIS, Inc. is recalling 68 units of the ConForMIS iUni Unicondylar Knee Replacement System, specifically the iUNI 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 recall includes specific catalog numbers and serial numbers for both US and international markets.
Consumers and healthcare providers who have purchased or used these specific devices should contact ConForMIS, Inc. for further instructions on how to proceed with the recall.
The recalled product
- Product
- ConForMIS iUni Unicondylar Knee Replacement System- iUNI G2, Right Medial Catalog Number:M57220600220 (US) M5722INT0600220 (OUS)
- Manufacturer
- ConforMIS, Inc.
- Affected units
- 68
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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