# FDA recall Z-3209-2018

> **Exactech, Inc.** · Class II · device recall initiated 2018-05-08.

## Product

Optetrak Logic CC Stem Extension, 22mm x 160mm    The OPTETRAK Logic CC Total Knee System is 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

Potentially have non-conforming internal threads.

## Distribution

US Distribution to Ohio only.

## Key facts

- **Recall number:** Z-3209-2018
- **Recalling firm:** Exactech, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2018-05-08
- **Report date:** 2018-09-26

- **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-3209-2018

## Citation

> AI Analytics. FDA recall Z-3209-2018. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-3209-2018. Source: US FDA. Licensed CC0.

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