BioPro recalled 147 femoral head components distributed in the US. The devices cover metal cobalt chromium and ceramic heads in sizes 22, 28, 32, 36 and 40 millimeters. The recall cites a packaging defect that could compromise the sterile barrier. If implanted, the loss of sterility could pose infection risk. Hospitals and surgeons should follow BioPro recall instructions immediately.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact BioPro, Inc. or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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BioPro femoral head components are used in hip replacement procedures. They are available in metal cobalt chromium and ceramic variants and come in multiple sizes to fit patient anatomy.
A packaging defect could allow the sterile barrier to be compromised, risking infection if implanted.
This recall is not described as part of a broader industry pattern in the notice.
Hospitals and surgical teams must verify sterile packaging integrity. Potential infection risk could prompt reoperations or delays in treatment.
Part IDs and distribution details are in the recall listing and FDA enforcement report
Replacement and refund timelines are determined by BioPro; refer to the recall notice for next steps
Keep copies of the recall notice, supplier communications, and surgical records related to implants
Brand: BioPro. Product: Femoral Head components (Metal 22, 28, 32, 36, 40; cobalt chromium and ceramic). Part IDs include 18593 through 19135 with multiple ±/+ size variants. Quantity: 147 total units. Distribution: US Domestic to Texas and Michigan. Date recalled: 2025-09-09. Date reported: 2025-10-22.
No injuries or incidents have been reported.
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