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ConforMIS, Inc. recalls ConFormis iTotal CR Knee Replacement System- iTOTAL CR, Right Knee Catalog Number: M57250600020 (US)
Recalled October 28, 2015 · FDA recall Z-0146-2016 · ConforMIS
Hazard
May contain small amounts of ethylene glycol residue · FDA Class II
Units
348 units
Sold at
Distributed Nationwide and in Germany, Switzerland, and UK.
Description
May contain small amounts of ethylene glycol residue
Product
ConFormis iTotal CR Knee Replacement System- iTOTAL CR, Right Knee Catalog Number: M57250600020 (US) M5725INT0600020 (OUS)
Manufacturer(s)
ConforMIS, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →