# FDA recall Z-2156-2024

> **Exactech, Inc.** · Class II · device recall initiated 2024-04-18.

## Product

OPTETRAK One Peg Patella,, Item Numbers:    a)	200-03-26, 26MM;   b)	200-03-29, 29MM;   c)	200-03-32, 32MM;   d)	200-03-35, 35MM;   e)	200-03-38, 38MM;   f)	200-03-41, 41MM

## Reason for recall

Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.

## Distribution

Worldwide distribution.

## Key facts

- **Recall number:** Z-2156-2024
- **Recalling firm:** Exactech, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-04-18
- **Report date:** 2024-06-26

- **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-2156-2024

## Citation

> AI Analytics. FDA recall Z-2156-2024. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2156-2024. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*