Z-2578-2026Class II

Brand Name: Persona Revision Product Name: Persona Revision Trabecular Metal Femoral Distal Augment...

Name: Z-2578-2026 Brand Name: Persona Revision Product Name: Persona Revision Trabecular Metal Femoral Distal Augment...
Creator: Zimmer, Inc.
Published: 2026-05-11
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2026-05-11 / Open, Classified / root cause: labeling and UDI

FDA source

Zimmer, Inc. began a recall of Brand Name: Persona Revision Product Name: Persona Revision Trabecular Metal Femoral Distal Augment Model/Catalog Number: 42-5572-066-10 Software Version: N/A... on 2026-05-11. FDA classified it as Class II and gives the reason as "Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2578-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-11
Posted: 2026-06-24
Recalling firm: Zimmer GmbH
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
Product code: MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Reason for recall: Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.
Root cause tag: labeling and UDI
FDA 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 in commerce: 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.
Product codes and lots: Lot Code: Model No. 42-5572-066-10 ; UDI-DI (01)00889024561014(17)331103(10)66232947 ; Lot number 66232947

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2578-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2578-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-01	2026-06-24

Product code MBH

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)