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Persona Trabecular Metal recallZ-2578-2026 · Zimmer, Inc. · initiated May 11, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Zimmer, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Labeling Change Control

What the company is doing

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.

Recall details

Recall number
Z-2578-2026
Status
Open, Classified
Initiated by the company
May 11, 2026
Posted by the FDA
Jun 24, 2026
Recalling firm
Zimmer, Inc.
Quantity
12
Product code
MBH
FDA submissions
K181947, K191625, K210551
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.

Product 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

Code information (models, lots, serial numbers)

Lot Code: Model No. 42-5572-066-10 ; UDI-DI (01)00889024561014(17)331103(10)66232947 ; Lot number 66232947

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

160 devices cleared under K181947, K191625, K210551 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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