Exactech, Inc. recalls Truliant Tibial Trial Handle. To assist the surgeon in the implantation of Truliant Knee system components according to…

Recall date

June 23, 2017

Source

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

Recall number

Z-3018-2017

FDA classification

Class II

Brand / firm

Exactech, Inc.

Sold / distributed

US Distribution to the states of : AZ, CA, CO, FL, IL, OH, OK, NV, NY, SC and TN.

Why it was recalled

The Truliant Tibial Trial Handle's pin may disassociate from the main body.

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 Tibial Trial Handle. To assist the surgeon in the implantation of Truliant Knee system components according to a conventional technique for total knee replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.t Tibial Trial Handle