# FDA recall Z-3018-2017

> **Exactech, Inc.** · Class II · device recall initiated 2017-06-23.

## Product

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

## Reason for recall

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

## Distribution

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

## Key facts

- **Recall number:** Z-3018-2017
- **Recalling firm:** Exactech, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-23
- **Report date:** 2017-08-23
- **Termination date:** 2020-11-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Gainesville, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3018-2017

## Citation

> AI Analytics. FDA recall Z-3018-2017. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-3018-2017. Source: US FDA. Licensed CC0.

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