ConFormis iTotal CR Knee Replacement System Recalled for Ethylene Glycol Residue
ConforMIS, Inc. is recalling 348 units of the iTotal CR Knee Replacement System because they may contain 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, which typically indicates a temporary or medically reversible adverse health consequence. The source text notes 'small amounts' of residue and does not report specific injuries or illnesses, aligning with a moderate severity rating for a precautionary recall of a medical device.
Plain-English summary
ConforMIS, Inc. is recalling 348 units of the ConFormis iTotal CR Knee Replacement System, specifically the iTOTAL CR, Right Knee model (Catalog Number M57250600020 for the US and M5725INT0600020 for outside the US). The recall was initiated 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 covers specific serial numbers for both US and non-US markets, which are listed in the official FDA recall record Z-0146-2016.
Healthcare providers and patients should check their device serial numbers against the list provided by the FDA or the manufacturer. If a device is found to be part of this recall, it should be removed from service and returned to ConforMIS, Inc. for further instructions.
The recalled product
- Product
- ConFormis iTotal CR Knee Replacement System- iTOTAL CR, Right Knee Catalog Number: M57250600020 (US) M5725INT0600020 (OUS)
- Manufacturer
- ConforMIS, Inc.
- Hazard
- Affected units
- 348
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 contamination
See all →- ModerateAVID Medical Recalls Plastic Trays Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAVID Medical Recalls Craniotomy Packs Due to Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAvid Medical Recalls 30 DAVINCI LAP/GYN Kits for Lubricant Contamination
FDA (Devices) · 2026-10-14
- HighFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- SevereFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateConformis iTotal Knee Replacement System Recalled for Incorrect Component
FDA (Devices) · 2016-03-16
- ModerateConforMIS iTotal Knee Replacement System Recalled for Incorrect Serial Number Labeling
FDA (Devices) · 2016-12-07
- ModerateConformis iTotal CR Knee Replacement System Recalled for Labeling Addendum
FDA (Devices) · 2012-08-29
- ModerateConformis Recalls Two iTotal CR Total Knee Replacement Systems
FDA (Devices) · 2019-04-17
- ModerateConformis iTotal CR G2 Knee Replacement System Recalled for Incorrect Serial Numbers
FDA (Devices) · 2014-12-17
- HighConformis Recalls iTotal CR Knee Replacement System Due to Fit Issues
FDA (Devices) · 2019-12-18