# FDA recall Z-1165-2025

> **Exactech, Inc.** · Class II · device recall initiated 2024-12-31.

## Product

AcuMatch XLE  Item Number / Product Description:  140-28-27	AM EHXL 0¿ LNR G 28MM  140-32-27	AM EHXL 0¿ LNR G 32MM  140-32-28	AM EHXL 0¿ LNR H 32MM  140-28-29	AM EHXL 0¿ LNR J 28MM  140-32-29	AM EHXL 0¿ LNR J 32MM  140-36-29	AM EHXL 0¿ LNR J 36MM  140-32-30	AM EHXL 0¿ LNR K 32MM  140-36-30	AM EHXL 0¿ LNR K 36MM  140-28-25	AM EHXL 0¿LNR E 28MM  140-28-26	AM EHXL 0¿LNR F 28MM  140-28-28	AM EHXL 0¿LNR H 28MM  140-36-28	AM EHXL 0¿LNR H 36MM  140-28-30	AM EHXL 0¿LNR K 28MM  142-28-24	AM EHXL 15¿ LNR D 28MM  142-28-26	AM EHXL 15¿ LNR F 28MM  142-32-27	AM EHXL 15¿ LNR G 32MM  142-32-28	AM EHXL 15¿ LNR H 32MM  142-36-28	AM EHXL 15¿ LNR H 36MM  142-36-29	AM EHXL 15¿ LNR J 26MM  142-28-29	AM EHXL 15¿ LNR J 28MM  142-32-29	AM EHXL 15¿ LNR J 32MM  142-28-30	AM EHXL 15¿ LNR K 28MM  142-32-30	AM EHXL 15¿ LNR K 32MM  142-36-30	AM EHXL 15¿ LNR K 36MM  142-28-25	AM EHXL 15¿LNR E 28MM  142-28-27	AM EHXL 15¿LNR G 28MM  142-28-28	AM EHXL 15¿LNR H 28MM  144-28-28	AM EHXL EXT LNR H 28MM  144-28-29	AM EHXL E

## Reason for recall

Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.

## Distribution

U.S.: AR, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MD, MN, NV, NY, OH, OK, PR,SC, TN, TX and VA  O.U.S.: Argentina, Colombia, Germany, Guatemala, Japan and Spain

## Key facts

- **Recall number:** Z-1165-2025
- **Recalling firm:** Exactech, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-12-31
- **Report date:** 2025-02-19

- **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-1165-2025

## Citation

> AI Analytics. FDA recall Z-1165-2025. Retrieved 2026-07-02 from https://api.ai-analytics.org/recall/Z-1165-2025. Source: US FDA. Licensed CC0.

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