BioPro, Inc. recalls BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT 14090 HEAD…

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.

Consignees were notified on September 9, 2025, via phone, followed by formal letters with instructions for returning the inventory to BioPro.

• FDA enforcement recordOfficial FDA database entry for Z-0153-2026
• FDA 510(k) clearance · K872856The device's official FDA premarket clearance record
• FDA device classification · JDIOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3350The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find BioPro, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.