BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT 14090 HEAD FEMORAL 28 MD LT 14091 HEAD FEM
Summary
The FDA issued a Class II for BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT 140 by BioPro, Inc.. Reason: Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk o.
Details
Source
Device Recall
External ID
Z-0153-2026
Action Date
2025-10-22
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: Product ID/UDI-DI 14089 M20914089 14090 M20914090 14091 M20914091 14094 M20914094 14095 M20914095 14096 M20914096 All lots, all serial numbers
Quantity Affected: 147 total
Reason for Recall
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.
Distribution
US Domestic distribution to Texas and Michigan.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-09
Company
Port Huron, MI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 237 device recalls issued in the same week, part of 403 device-related FDA actions this month.
BioPro, Inc. has 16 FDA actions in our database, including 16 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (BioPro, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does BioPro, Inc. have FDA actions?
BioPro, Inc. has 16 FDA actions in our database, including 16 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0153-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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