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
- Company
- Biopro, Inc.
- Recall Initiated
- September 9, 2025
- Posted
- October 14, 2025
- Recall Number
- Z-0151-2026
- Quantity
- 147 total
- Firm Location
- Port Huron, MI
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.
Lot / Code Info
Product ID/UDI-DI 19023 M20919023 19024 M20919024 19025 M20919025 19026 M20919026 19027 M20919027 All lots, all serial numbers
Root Cause
Package design/selection
Action Taken
Consignees were notified on September 9, 2025, via phone, followed by formal letters with instructions for returning the inventory to BioPro.
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