BioPro recalled 147 BioPro Femoral Head hip implant components sold in Texas and Michigan after a packaging defect could compromise sterility. The defect may result in loss of sterility, creating a risk of infection if implanted. Hospitals and clinicians should stop using the devices and await manufacturer instructions.
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. The devices are supplied as part of total hip arthroplasty implants and are intended for use by surgeons in operating rooms.
A packaging defect could fail to preserve the sterile barrier. If a device is implanted and sterility is compromised, there is a risk of postoperative infection.
This recall is not described as part of a broader industry pattern in the provided information.
The immediate impact is a halt in use of the affected devices and coordination between BioPro and healthcare providers to identify and replace affected lots. The recall could affect patient care decisions and hospital inventories.
UDI-DI or model IDs are often printed on the device packaging and accompanying documentation. Use the recall notice for exact identifiers.
Recall processing and replacement coordination typically occur within weeks to a couple of months, depending on facilities and patient conditions.
Keep all recall communications, device identifiers, and correspondence with BioPro and healthcare providers. Document actions taken and retain packaging for evidence.
Product IDs: 14089, 14090, 14091, 14094, 14095, 14096. UDI-DI mappings: 14089 M20914089, 14090 M20914090, 14091 M20914091, 14094 M20914094, 14095 M20914095, 14096 M20914096. All lots and all serial numbers are affected. Quantity: 147 units. US distribution: Texas and Michigan. Recall date: 2025-09-09. Report date: 2025-10-22. Manufacturer: BioPro, Inc. Status: ACTIVE.
No injuries or incidents have been reported.
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