⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

BioPro, Inc.: BioPro Femoral Head (Ceramic heads 28-30) Product ID/Description 19023 HEAD FEMORAL CERAMIC 28MM -3 19024 HEAD FEMORAL CERAMIC 28MM +0

Medical DevicesSource: FDA (device) · Date: 2025-10-22

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
BioPro, Inc.
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 / hazard
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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Domestic distribution to Texas and Michigan.
Recall initiated
2025-09-09
Code info
Product ID/UDI-DI 19023 M20919023 19024 M20919024 19025 M20919025 19026 M20919026 19027 M20919027 All lots, all serial numbers
Product quantity
147 total
Voluntary mandated
Voluntary: Firm initiated
City
Port Huron
State
MI
Country
United States
Event id
97605
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