Recall Z-0152-2026— BioPro, Inc.

Name: FDA recall Z-0152-2026
Creator: U.S. Food and Drug Administration
Published: 2025-09-09

Class II · Ongoing

Class II FDA medical device recall by BioPro, Inc., initiated 2025-09-09. It names one FDA 510(k) clearance: K954768. Product: BioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERAMIC SH 38 13012 ENDO MODULAR CERAMIC SH 51 13013 ENDO MODULAR CERAMIC MD 38 13019 ENDO MODULAR CERAMIC MD 51 13007 ENDO MODULAR CERAMIC SH 41 13008 ENDO MODULAR CERAMIC SH 43 13009 ENDO MODULAR CERAMIC SH 45 13010 ENDO MODULAR CERAMIC SH 47 13011 ENDO MODULAR CERAMIC SH 49 13014 ENDO MODULAR CERAMIC MD 41 13015 ENDO MODULAR CERAMIC MD 43 13016 ENDO MODULAR CERAMIC MD 45 13017 ENDO MODULAR CERAMIC MD 47 13018 ENDO MODULAR CERAMIC MD 49 14823 ENDO MODULAR CERAMIC SH 53 14824 ENDO MODULAR CERAMIC MD 53 14825 ENDO MODULAR CERAMIC SH 55 14826 ENDO MODULAR CERAMIC MD 55 17295 ENDO MODULAR CERAMIC SH 36 17296 ENDO MODULAR CERAMIC MD 36. Reason: 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..

Recalling firm: BioPro, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-09-09
Firm location: Port Huron, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K954768 — BIOPRO HEMI-ENDO MODULAR CERAMIC HEADBiologically Oriented Prostheses·cleared 1996-01-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

BioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERAMIC SH 38 13012 ENDO MODULAR CERAMIC SH 51 13013 ENDO MODULAR CERAMIC MD 38 13019 ENDO MODULAR CERAMIC MD 51 13007 ENDO MODULAR CERAMIC SH 41 13008 ENDO MODULAR CERAMIC SH 43 13009 ENDO MODULAR CERAMIC SH 45 13010 ENDO MODULAR CERAMIC SH 47 13011 ENDO MODULAR CERAMIC SH 49 13014 ENDO MODULAR CERAMIC MD 41 13015 ENDO MODULAR CERAMIC MD 43 13016 ENDO MODULAR CERAMIC MD 45 13017 ENDO MODULAR CERAMIC MD 47 13018 ENDO MODULAR CERAMIC MD 49 14823 ENDO MODULAR CERAMIC SH 53 14824 ENDO MODULAR CERAMIC MD 53 14825 ENDO MODULAR CERAMIC SH 55 14826 ENDO MODULAR CERAMIC MD 55 17295 ENDO MODULAR CERAMIC SH 36 17296 ENDO MODULAR CERAMIC MD 36

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.