Brand Name: Persona Revision Product Name: Persona Revision Trabecular Metal Femoral Distal Augment Model/Catalog Number
FDA device recall Z-2578-2026 · posted 2026-06-24 · Open, Classified
Recall details
- Recalling firm
- Zimmer, Inc.
- Reason for recall
- Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.
- Action taken
- On May 11, 2026, the firm began notifying consignees via letters titled "URGENT MEDICAL DEVICE RECALL." Customers were instructed to review the notification and ensure affected personnel are aware of the contents. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine affected product. The sales representative will remove the affected product from your facility. If product has been further distributed, provide your customers with the recall notice and ensure documentation.
- Root cause
- Labeling Change Control
- Status
- Open, Classified
- Product code
- MBH
- Quantity affected
- 12
- Distribution
- 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.
- Date initiated
- 2026-05-11
- Date posted
- 2026-06-24
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Persona Revision Knee System (K210551) | Zimmer, Inc. | 2021-03-18 |
| Persona Revision Knee System (K191625) | Zimmer, Inc. | 2019-09-05 |
| Persona Revision Knee System (K181947) | Zimmer, Inc. | 2018-10-25 |