Class II — Zimmer, Inc.
| Recalling firm | ZIMMER, INC. |
|---|---|
| Registered facility | View this company's 10 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package. |
| Product | 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 |
| 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. |
| Initiated | 2026-05-11 |
| Classified | 2026-06-24 |
| Recall number | Z-2578-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Zimmer, Inc. (Z-2578-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99073/
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