Medical Device Recall: BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part ID/Description: 18593 HEAD FEMORAL 22MM -3 18594 HEAD FEMORAL 22MM +0 19003 HEAD FEMORAL 28MM-6 19004 HEAD
BioPro, Inc. · September 9, 2025
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.
Product Description
BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part ID/Description: 18593 HEAD FEMORAL 22MM -3 18594 HEAD FEMORAL 22MM +0 19003 HEAD FEMORAL 28MM-6 19004 HEAD FEMORAL 28MM-3 19005 HEAD FEMORAL 28MM+0 19006 HEAD FEMORAL 28MM+3 19007 HEAD FEMORAL 28MM+6 19008 HEAD FEMORAL 28MM+9 19053 HEAD FEMORAL 36MM -3 19054 HEAD FEMORAL 36MM +0 19055 HEAD FEMORAL 36MM +3 19056 HEAD FEMORAL 36MM +6 19057 HEAD FEMORAL 36MM +9 19130 HEAD FEMORAL 32MM-6 19131 HEAD FEMORAL 32MM-3 19132 HEAD FEMORAL 32MM+0 19133 HEAD FEMORAL 32MM +3 19134 HEAD FEMORAL 32MM+6 19135 HEAD FEMORAL 32MM +9
Distribution
US Domestic distribution to Texas and Michigan.
Quantity Affected
147 total
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0148-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.