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ConforMIS, Inc. recalls ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number: TCR-111-1111. Intended for
Recalled December 7, 2016 · FDA recall Z-0658-2017 · ConforMIS
Hazard
Mislabeled: incorrect serial number on the F4 A/P cut guide iJig. · FDA Class II
Units
2 units
Sold at
Distributed to the states of CO and NV.
Description
Mislabeled: incorrect serial number on the F4 A/P cut guide iJig.
Product
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.
Manufacturer(s)
ConforMIS, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →