Device product
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.
Z-1364-2020
Product summary
- Firm
- Exactech, Inc.
- Event
- Event 84961
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4 units
- Official record key
device-enforcement:Z-1364-2020
Official wording
Reason: 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.
Code information: Catalog no: 02-012-64-1812 Serial number: 6366405, 6367075, 6367076
Distribution pattern: US Nationwide distribution in the states of AZ, CO and FL.
Derived failure modes
-
Labeling or packaging
labeling error