BioPro Femoral Head Recall: Potential Sterile Packaging Compromise
BioPro is recalling certain femoral head hip replacement components due to a potential packaging issue that could compromise sterility. The defect may result in loss of sterility, risking infection in implanted devices.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall due to potential packaging compromise affecting sterile barrier of an implanted orthopedic device. No illnesses or injuries reported, but the hazard—loss of sterility leading to infection risk—presents significant potential harm; Class II classification confirms this is not the highest severity category.
Plain-English summary
BioPro, Inc. is recalling certain BioPro Femoral Head hip replacement components due to a potential packaging issue that could compromise the sterile barrier of the devices. The affected product IDs are 14089, 14090, 14091, 14094, 14095, and 14096, covering 147 units distributed domestically to Texas and Michigan.
If the packaging is compromised, the device may lose sterility, which could present a risk of infection if implanted. No illnesses or injuries have been reported to date.
Patients who have received one of these femoral head components should contact their healthcare provider or surgeon immediately. Do not attempt to remove or replace the device yourself. Your healthcare provider can determine whether the device requires evaluation or replacement.
The recalled product
- Product
- BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT 14090 HEAD FEMORAL 28 MD LT 14091 HEAD FEMORAL 28 LG LT 14094 HEAD FEMORAL 32 SH LT 14095 HEAD FEMORAL 32 MD LT 14096 HEAD FEMORAL 32 LG LT
- Manufacturer
- BioPro, Inc.
- Hazard
- sterility-compromise
- infection-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- all serial numbers
Distribution
Distribution scope not specified by the agency.
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