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.
What this means for you
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.
See all 11 products in this recall →Related recalls
Same manufacturer · ConforMIS, Inc.
See all →- HighConformis Restor3d Cordera Hip Acetabular Liner Mislabeled
FDA (Devices) · 2025-04-23
- HighConformis Identity Imprint PS Tibial Tray Size 4 Packaging Error
FDA (Devices) · 2024-04-24
- HighHip Screw Labeled as Wrong Size: 30mm Screws Mislabeled as 25mm
FDA (Devices) · 2023-08-23
- HighiTotal Identity Impactor Handle surgical screws may loosen during procedures
FDA (Devices) · 2023-02-22
- HighiTotal Identity Knee Replacement System—incorrect tibial base plate packaged
FDA (Devices) · 2022-04-20
Same hazard · chemical residue
See all →- HighKnee Procedure Kit Recalled for Elevated Chemical Residuals
FDA (Devices) · 2024-07-17
- HighProcedure Kit Recalled for Excess Ethylene Oxide Residue in Cast Padding
FDA (Devices) · 2024-07-17
- HighProcedure Tray Recalled for Excessive Ethylene Oxide Residuals
FDA (Devices) · 2024-07-17
- HighHand Procedure Kit Recalled for Excess Ethylene Oxide Residuals
FDA (Devices) · 2024-07-17
- ModeratePeak Harvest salad kits recalled due to incorrect washing chemical
FDA (Food) · 2023-01-18