FDA-Device2020-03-04Class II
Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented total knee prosthesis system, which provides femoral components, tibial inserts, stems, augments, and surgical instrumentation for use in primary and revision total knee arthroplasty.
Exactech, Inc.
Hazard
These Truliant Splined Stem Extension, 18mm x 120mm were found to have a labeling error. The upper right corner of the label incorrectly identifies the implant size as 17mm x 80mm when the implant size is 18mm x 120mm.
Sold states
US Nationwide distribution in the states of AZ, CO and FL.
Affected count
4 units
Manufactured in
2320 NW 66th Ct, N/A, Gainesville, FL, United States
Products
Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented total knee prosthesis system, which provides femoral components, tibial inserts, stems, augments, and surgical instrumentation for use in primary and revision total knee arthroplasty.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1364-2020Don't want to check this manually?
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