The Recall Desk
HighFDA (Devices)·Z-0145-2016·Announced 2015-10-28

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.

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 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.
Category
Medical Device — Orthopedic Implant
Hazard
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 →

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