FDA-Device2015-10-28Class II
ConFormis iTotal CR Knee Replacement System- iTOTAL CR, Right Knee Catalog Number: M57250600020 (US) M5725INT0600020 (OUS)
ConforMIS, Inc.
Hazard
May contain small amounts of ethylene glycol residue
Sold states
Distributed Nationwide and in Germany, Switzerland, and UK.
Affected count
348 units
Manufactured in
28 Crosby Dr, N/A, Bedford, MA, United States
Products
ConFormis iTotal CR Knee Replacement System- iTOTAL CR, Right Knee Catalog Number: M57250600020 (US) M5725INT0600020 (OUS)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0146-2016Don't want to check this manually?
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