FDA-Device2014-12-17Class II
Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010 Intended for use as a total knee replacement in patients with knee joint pain and disability.
ConforMIS, Inc.
Hazard
Incorrect serial number of tibial inserts packaged in tray may result in inserts not fitting
Sold states
Distributed to IN.
Affected count
1 unit
Manufactured in
28 Crosby Dr, N/A, Bedford, MA, United States
Products
Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010 Intended for use as a total knee replacement in patients with knee joint pain and disability.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0581-2015Don't want to check this manually?
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