The Recall Desk
ModerateFDA (Devices)·Z-0146-2016·Announced 2015-10-28

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.

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, 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.
Category
Medical Device — Orthopedic Implant
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 →

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