Recall Z-2578-2026 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Zimmer, Inc.
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
| Date | Jun 24, 2026 (initiated May 11, 2026) |
| Status | Open, Classified |
| Reason | Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package. |
| Root cause | Labeling Change Control |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |