# FDA recall Z-2640-2025

> **Howmedica Osteonics Corp.** · Class II · device recall initiated 2025-08-28.

## Product

1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442;  2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0580-1-352;

## Reason for recall

a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa. Patient labels may also be impacted.

## Distribution

International distribution in the country of United Kingdom.

## Key facts

- **Recall number:** Z-2640-2025
- **Recalling firm:** Howmedica Osteonics Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-08-28
- **Report date:** 2025-10-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mahwah, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2640-2025

## Citation

> AI Analytics. FDA recall Z-2640-2025. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-2640-2025. Source: US FDA. Licensed CC0.

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