medical Class II Updated 2020-03-04

Exactech, Inc. recalls Truliant Splined Stem Extension, 18mm x 120mm - Product Usag

Recalled 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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Catalog no: 02-012-64-1812 Serial number: 6366405, 6367075, 6367076
View official government recall

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