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
FDA Recall Z-2578-2026 · Posted 2026-06-24
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Recalling FirmZimmer, Inc.
Recall StatusOpen, Classified
Product CodeMBH
Date Initiated2026-05-11
Product Quantity12
Reason for Recall
Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.
Firm 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.
Root Cause
Labeling Change Control
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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