# FDA recall Z-0151-2026

> **BioPro, Inc.** · Class II · device recall initiated 2025-09-09.

## Product

BioPro Femoral Head (Ceramic heads 28-30)    Product ID/Description  19023	HEAD FEMORAL CERAMIC 28MM -3  19024	HEAD FEMORAL CERAMIC 28MM +0  19025	HEAD FEMORAL CERAMIC 32MM -3  19026	HEAD FEMORAL CERAMIC 32MM +0  19027	HEAD FEMORAL CERAMIC 32MM +3

## Reason for recall

Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.

## Distribution

US Domestic distribution to Texas and Michigan.

## Key facts

- **Recall number:** Z-0151-2026
- **Recalling firm:** BioPro, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-09
- **Report date:** 2025-10-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Port Huron, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0151-2026

## Citation

> AI Analytics. FDA recall Z-0151-2026. Retrieved 2026-08-19 from https://api.ai-analytics.org/recall/Z-0151-2026. Source: US FDA. Licensed CC0.

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