Brand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Metal¿ Femoral Distal Au...
FDA Device Recall #Z-2578-2026 - Class II, May 11, 2026
Recall Summary
| Recall Number | Z-2578-2026 |
| Classification | Class II - Moderate risk |
| Date Initiated | May 11, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Zimmer, Inc. |
| Location | Warsaw, IN |
| Product Type | Devices |
| Quantity | 12 |
Product Description
Brand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment Model/Catalog Number: 42-5572-066-10 Software Version: N/A Product Description: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment Size 9, 9+ 10mm Thicknes Component: N/A
Reason for Recall
Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.
Distribution Pattern
Refer to the attached ZFA 2026-00088_Initial Consignee List and ZFA 2026-00088_Initial Distribution History containing the distribution and the identification of the affected consignees.
Lot / Code Information
Lot Code: Model No. 42-5572-066-10 ; UDI-DI (01)00889024561014(17)331103(10)66232947 ; Lot number 66232947
Other Recalls from Zimmer, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2529-2026 | Class II | Off-Axis Comprehensive Shoulder System, Large, ... | May 20, 2026 |
| Z-2527-2026 | Class II | Off-Axis Comprehensive Shoulder System Small, A... | May 20, 2026 |
| Z-2530-2026 | Class II | Off-Axis Alliance Glenoid, Left, 4-Peg, Augment... | May 20, 2026 |
| Z-2531-2026 | Class II | Off-Axis Alliance Glenoid, Right, 4-Peg, Augmen... | May 20, 2026 |
| Z-2528-2026 | Class II | Off-Axis Comprehensive Shoulder System, Medium,... | May 20, 2026 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.