ConFormis iDUO G2 Knee Implant Recalled for Ethylene Glycol Residue
ConforMIS, Inc. is recalling one unit of the ConFormis iDUO G2 knee implant due to potential 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 involves a medical device with a potential chemical contamination (ethylene glycol) where no specific injuries or illnesses are reported in the source text, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
ConforMIS, Inc. is recalling one unit of the ConFormis iDUO G2, Right Lateral knee implant (Catalog Number: M5723INT0600240). The recall is being conducted because the device may contain small amounts of ethylene glycol residue.
The affected unit has the serial number OUS 0354195. The product was distributed nationwide in the United States, as well as in Germany, Switzerland, and the United Kingdom.
Consumers and healthcare providers should contact ConforMIS, Inc. for further instructions regarding the return or replacement of the affected device.
The recalled product
- Product
- ConFormis iDUO G2, Right Lateral Catalog Number: M5723INT0600240 (US) M5723INT0600240 (OUS)
- Manufacturer
- ConforMIS, Inc.
- Hazard
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial Number: OUS 0354195
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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