FDA-Device2015-10-28Class II

ConForMIS Unicondylar Knee Replacement System iUNI G2, Left Medial Catalog Number: M57220600210(US) M5722INT0600210 (OUS)

ConforMIS, Inc.
Hazard

May contain small amounts of ethylene glycol residue

Sold states
Distributed Nationwide and in Germany, Switzerland, and UK.
Affected count
71 units
Manufactured in
28 Crosby Dr, N/A, Bedford, MA, United States
Products
ConForMIS Unicondylar Knee Replacement System iUNI G2, Left Medial Catalog Number: M57220600210(US) M5722INT0600210 (OUS)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0139-2016

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