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ConforMIS, Inc. recalls ConFormis iTotal Posterior Stabilized Knee Replacement System- ITOTAL PS-IPOLY- IMPLANT KIT-LEFT and ITOTAL PS-IPOLY
Recalled October 28, 2015 · FDA recall Z-0147-2016 · ConforMIS
Hazard
May contain small amounts of ethylene glycol residue · FDA Class II
Units
110 units
Sold at
Distributed Nationwide and in Germany, Switzerland, and UK.
Description
May contain small amounts of ethylene glycol residue
Product
ConFormis iTotal Posterior Stabilized Knee Replacement System- ITOTAL PS-IPOLY- IMPLANT KIT-LEFT and ITOTAL PS-IPOLY-IMPLANT KIT-RIGHT Catalog Number:TPS1111111
Manufacturer(s)
ConforMIS, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →