BioPro recalled 147 femoral head components on September 9, 2025. A packaging defect may compromise sterility, increasing infection risk. The recall affects models distributed in Texas and Michigan.
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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The recall includes BioPro Femoral Heads with part IDs 18593, 18594, 19003, 19004, 19005, 19006, 19007, 19008, 19053, 19054, 19055, 19056, 19057, 19130, 19131, 19132, 19133, 19134, and 19135. These components were distributed domestically in the United States.
A potential packaging issue may compromise the sterile barrier of these medical devices. Loss of sterility could lead to a serious risk of infection if the device is implanted.
As of now, no specific injuries or incidents have been reported related to this recall. However, the risk of infection poses a significant health concern.
Patients and healthcare providers should stop using these femoral head components immediately. Contact BioPro, Inc. or your healthcare provider for further instructions.
For more information, visit the BioPro website or call their customer support. Detailed recall instructions can also be found through the FDA's enforcement report.
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