ConForMIS iTotal CR Knee Replacement System Recalled for Ethylene Glycol Residue
ConforMIS, Inc. is recalling 313 units of the iTotal CR Knee Replacement System 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 3/5 (High).
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 is classified as FDA Class II, which indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The presence of ethylene glycol residue in an implanted medical device represents a significant risk of harm, even if the amount is described as small.
Plain-English summary
ConforMIS, Inc. is recalling 313 units of the ConForMIS iTotal CR (Cruciate Retaining) Knee Replacement System, specifically the Left Knee model. The recall is being conducted because the devices may contain small amounts of ethylene glycol residue.
The affected products are identified by Catalog Numbers M57250600010 (US) and M5725INT0600010 (OUS). The recall covers units distributed nationwide in the United States, as well as in Germany, Switzerland, and the UK. Specific serial numbers for both US and out-of-US (OUS) units are listed in the official recall documentation.
This is an FDA Class II recall. Consumers and healthcare providers should check their inventory or patient records against the provided serial numbers. If a unit is affected, it should be removed from use and returned to the manufacturer or an authorized distributor for evaluation and replacement.
The recalled product
- Product
- ConForMIS iTotal CR (Cruciate Retaining) Knee Replacement System-iTOTAL CR, Left Knee Catalog Number: M57250600010 (US) M5725INT0600010 (OUS)
- Manufacturer
- ConforMIS, Inc.
- Affected units
- 313
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 30 DAVINCI LAP/GYN Kits for 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 Plastic Trays Due to 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 G2 Knee Replacement System Recalled for Incorrect Serial Numbers
FDA (Devices) · 2014-12-17
- 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 Recalls Mislabeled Total Knee Replacement Implant Kits
FDA (Devices) · 2018-02-21