Exactech, Inc. recalls Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented total knee prosthesis…

Recall date

January 27, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1364-2020

FDA classification

Class II

Brand / firm

Exactech, Inc.

Sold / distributed

US Nationwide distribution in the states of AZ, CO and FL.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.