FDA-Device2016-03-16Class II

Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111

ConforMIS, Inc.
Hazard

Incorrect femoral component distributed

Sold states
KY
Affected count
1 unit
Manufactured in
28 Crosby Dr, N/A, Bedford, MA, United States
Products
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1070-2016

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