FDAHealthSeptember 9, 2025
BioPro, Inc. — 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 HE
⚠️ 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.
Is this relevant to me?
- Geography
- US
- Source agency
- FDA
- Category
- Health
- Published
- September 9, 2025
US Domestic distribution to Texas and Michigan.
What's affected?
- 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
- Brand
- BioPro, Inc.
- Lot code
- s
Additional details
Product ID/UDI-DI 19023 M20919023 19024 M20919024 19025 M20919025 19026 M20919026 19027 M20919027 All lots, all serial numbers
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 147 total.
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