FDA-Device2015-10-28Class II
ConFormis iTotal Posterior Stabilized Knee Replacement System- ITOTAL PS-IPOLY- IMPLANT KIT-LEFT and ITOTAL PS-IPOLY-IMPLANT KIT-RIGHT Catalog Number:TPS1111111
ConforMIS, Inc.
Hazard
May contain small amounts of ethylene glycol residue
Sold states
Distributed Nationwide and in Germany, Switzerland, and UK.
Affected count
110 units
Manufactured in
28 Crosby Dr, N/A, Bedford, MA, United States
Products
ConFormis iTotal Posterior Stabilized Knee Replacement System- ITOTAL PS-IPOLY- IMPLANT KIT-LEFT and ITOTAL PS-IPOLY-IMPLANT KIT-RIGHT Catalog Number:TPS1111111
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0147-2016Don't want to check this manually?
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