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ConforMIS, Inc. recalls ConFormis iTotal CR Knee Replacement System- ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - LEFT ITOTAL CR - IPOLY - IMP
Recalled October 28, 2015 · FDA recall Z-0144-2016 · ConforMIS
Hazard
May contain small amounts of ethylene glycol residue · FDA Class II
Units
3 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 - IPOLY - IMPLANT KIT UNCAPTURED - LEFT ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - RIGHT Catalog Number: TCR1111111
Manufacturer(s)
ConforMIS, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →