# FDA recall Z-1406-2024

> **Exactech, Inc.** · Class II · device recall initiated 2024-03-06.

## Product

Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with:    a) 38, 41, 44, 47 head, Small, Item Number 314-02-22,   b) 41, 44, 47, 50 head, Medium,  Item Number 314-02-23,   c) 44, 47, 50, 53 head, Large,  Item Number 314-02-24,   d) 44, 47, 50, 53 head, Extra Large,  Item Number 314-02-25; Shoulder Arthroplasty

## Reason for recall

The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).

## Distribution

Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China, Colombia, France, Germany, Great Britain, Greece, Guatemala, India, Italy, Japan, Korea, Luxembourg, Malaysia, Netherlands, New Zealand, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand

## Key facts

- **Recall number:** Z-1406-2024
- **Recalling firm:** Exactech, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-03-06
- **Report date:** 2024-04-10

- **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-1406-2024

## Citation

> AI Analytics. FDA recall Z-1406-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1406-2024. Source: US FDA. Licensed CC0.

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