ConForMIS iDuo Knee Replacement Recalled for Ethylene Glycol Residue
ConForMIS is recalling iDuo Bicompartmental 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 is classified as FDA Class II, which falls under the 'High' severity category in the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
ConForMIS, Inc. is recalling the ConForMIS iDuo Bicompartmental Knee Replacement System, specifically the iDUO G2, Left Lateral model with Catalog Number M57230600230. The recall is being conducted because the product may contain small amounts of ethylene glycol residue.
The affected units are identified by Serial Number 0351869. The product was distributed nationwide in the United States, as well as in Germany, Switzerland, and the United Kingdom.
This is a Class II recall, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Patients who have received this implant should contact their healthcare provider for guidance.
The recalled product
- Product
- ConForMIS iDuo Bicompartmental Knee Replacement System iDUO G2, Left Lateral Catalog Number: M57230600230
- Manufacturer
- ConforMIS, Inc.
- Hazard
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 Numbers: 0351869
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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