HIGH

BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part ID/Description: 18593 HEAD FEMORAL 22MM -3 18594 HEAD FEMORAL 22MM +0 19003 HEAD FEMORAL 28MM-6 19004 HEAD...

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.

Quick Facts at a Glance

Recall Date
September 9, 2025
Hazard Level
HIGH
Brand
BioPro

Hazard Information

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.

What You Should Do

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

Full Description

BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part ID/Description: 18593 HEAD FEMORAL 22MM -3 18594 HEAD FEMORAL 22MM +0 19003 HEAD FEMORAL 28MM-6 19004 HEAD FEMORAL 28MM-3 19005 HEAD FEMORAL 28MM+0 19006 HEAD FEMORAL 28MM+3 19007 HEAD FEMORAL 28MM+6 19008 HEAD FEMORAL 28MM+9 19053 HEAD FEMORAL 36MM -3 19054 HEAD FEMORAL 36MM +0 19055 HEAD FEMORAL 36MM +3 19056 HEAD FEMORAL 36MM +6 19057 HEAD FEMORAL 36MM +9 19130 HEAD FEMORAL 32MM-6 19131 HEAD FEMORAL 32MM-3 19132 HEAD FEMORAL 32MM+0 19133 HEAD FEMORAL 32MM +3 19134 HEAD FEMORAL 32MM+6 19135 HEAD FEMORAL 32MM +9. Reason: 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.. Classification: Class II. Quantity: 147 total. Distribution: US Domestic distribution to Texas and Michigan.

View Original Recall on FDA - Medical Devices

Want Alerts Like This?

Get notified about recalls in categories you care about.

Product Classification

Product Details

Brand
BioPro
Model Numbers
Part ID/ UDI-DI: 18593 M20918593 18594 M20918594 19003 M20919003 19004 M20919004 19005 M20919005 19006 M20919006 19007 M20919007 19008 M20919008 19053 M20919053 19054 M20919054 19055 M20919055 19056 M20919056 19057 M20919057 19130 M20919130 19131 M20919131 19132 M20919132 19133 M20919133 19134 M20919134 19135 M20919135 All lots and serial numbers affected
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

Related Recalls

HIGH

Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]

CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.

SUCRALFATE
CGMP Deviations:
Read more