Skip to content
Recall Observatory FDA recall evidence

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

January 27, 2020

Class II

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

    reason.labeling_packaging · v1.0.0

    labeling error