Home / Recalls / Medical Devices
BioPro, Inc. recalls BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT 14090 HEAD FEMORAL 28 MD LT 14091 HEAD FEM
Recalled October 22, 2025 · FDA recall Z-0153-2026 · BioPro
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. · FDA Class II
Units
147 total
Sold at
US Domestic distribution to Texas and Michigan.
Description
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.
Product
BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT 14090 HEAD FEMORAL 28 MD LT 14091 HEAD FEMORAL 28 LG LT 14094 HEAD FEMORAL 32 SH LT 14095 HEAD FEMORAL 32 MD LT 14096 HEAD FEMORAL 32 LG LT
Manufacturer(s)
BioPro, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →