FDA-Device2015-10-28Class II
ConForMIS iTotal CR (Cruciate Retaining) Knee Replacement System-iTOTAL CR, Left Knee Catalog Number: M57250600010 (US) M5725INT0600010 (OUS)
ConforMIS, Inc.
Hazard
May contain small amounts of ethylene glycol residue
Sold states
Distributed Nationwide and in Germany, Switzerland, and UK.
Affected count
313 units
Manufactured in
28 Crosby Dr, N/A, Bedford, MA, United States
Products
ConForMIS iTotal CR (Cruciate Retaining) Knee Replacement System-iTOTAL CR, Left Knee Catalog Number: M57250600010 (US) M5725INT0600010 (OUS)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0145-2016Don't want to check this manually?
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