FDA DevicesClass II
Brand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Metal¿ ...
Published: July 1, 2026Recall ID: Z-2578-2026Category: devicesCountry: US
Reason for Recall / Hazard
Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.
Product Description & Identification
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
Affected Products
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
Additional Source Details
| Field | Value |
|---|---|
| City | Warsaw |
| State | IN |
| Event id | 99073 |
| Address 1 | 1800 W Center St |
| Address 2 | N/A |
| Code info | Lot Code: Model No. 42-5572-066-10 ; UDI-DI (01)00889024561014(17)331103(10)66232947 ; Lot number 66232947 |
| Postal code | 46580-2304 |
| Report date | 20260701 |
| Product type | Devices |
| Product quantity | 12 |
| Reason for recall | Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260511 |
| Initial firm notification | Letter |
| Center classification date | 20260624 |
Overview
- Recalling FirmZimmer, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionRefer 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.