Z-0151-2026 Class II Ongoing
FDA device recall Z-0151-2026 was initiated by BioPro, Inc. on September 9, 2025 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 147 total.
Recall Details
- Product Type
- Devices
- Report Date
- October 22, 2025
- Initiation Date
- September 9, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 147 total
Product Description
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 Pattern
US Domestic distribution to Texas and Michigan.
Code Information
Product ID/UDI-DI 19023 M20919023 19024 M20919024 19025 M20919025 19026 M20919026 19027 M20919027 All lots, all serial numbers