# FDA recall Z-2562-2025

> **Exactech, Inc.** · Class II · device recall initiated 2025-08-15.

## Product

Exactech Equinoxe, Reverse Shoulder Humeral Liners,   322-38-00 (145-DEG PE 38MM HUM LINER +0),  REF: 322-38-03 (145-DEG PE 38MM HUM LINER +2.5),  REF:322-42-00 (145-DEG PE 42MM HUM LINER +0),  REF: 322-42-03 (145-DEG PE 42MM HUM LINER +2.5)

## Reason for recall

Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.

## Distribution

Worldwide - US Nationwide distribution in the states of CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MN, NV, NY, OH, OK, PR, SC, TN, TX, VA, WI and the countries of Australia, Austria, Brazil, Canada, Colombia, France, United Kingdom, Guatemala, India, Italy, Japan, Korea, Germany, The Netherlands, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Dubai.

## Key facts

- **Recall number:** Z-2562-2025
- **Recalling firm:** Exactech, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-08-15
- **Report date:** 2025-09-24

- **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-2562-2025

## Citation

> AI Analytics. FDA recall Z-2562-2025. Retrieved 2026-08-24 from https://api.ai-analytics.org/recall/Z-2562-2025. Source: US FDA. Licensed CC0.

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