BEUDAMED
    FDA Recall Open, Classified

    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

    Recall: Z-2578-2026 · Initiated May 11, 2026

    Recall

    Recall Number
    Z-2578-2026
    Event Number
    99073
    Firm
    Zimmer, Inc.
    FEI Number
    1000220733
    Product Code
    MBH
    Status
    Open, Classified
    Root Cause
    Labeling Change Control
    Initiated
    May 11, 2026
    Posted
    June 24, 2026
    Address
    1800 W Center St, Warsaw, IN, 46580-2304

    Description

    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

    Reason

    Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.

    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.

    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.

    Quantity

    12