FDA-Device2016-12-07Class II
ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number: TCR-111-1111. Intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device.
ConforMIS, Inc.
Hazard
Mislabeled: incorrect serial number on the F4 A/P cut guide iJig.
Sold states
Distributed to the states of CO and NV.
Affected count
2 units
Manufactured in
28 Crosby Dr, Bedford, MA, United States
Products
ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number: TCR-111-1111. Intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0658-2017Don't want to check this manually?
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