# FDA recall Z-1208-2019

> **Exactech, Inc.** · Class II · device recall initiated 2019-03-13.

## Product

Truliant Tibial Fit Tray Cemented SZ 3F / 3T, Catalog Number 02-022-45-3030    Product Usage:  Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented The OPTETRAK Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems.

## Reason for recall

2.5 Truliant Fit Trays were mismarked as 3

## Distribution

US Nationwide Distribution in the states of AR, CA, OH, OK, IN, MN, NJ, TN, SC, FL

## Key facts

- **Recall number:** Z-1208-2019
- **Recalling firm:** Exactech, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-13
- **Report date:** 2019-05-01
- **Termination date:** 2021-04-22

- **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-1208-2019

## Citation

> AI Analytics. FDA recall Z-1208-2019. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-1208-2019. Source: US FDA. Licensed CC0.

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