Brand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment Model/Catalog Nu
Summary
The FDA issued a Class II for Brand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Metal¿ by Zimmer, Inc.. Reason: Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package..
Details
Source
Device Recall
External ID
Z-2578-2026
Action Date
2026-07-01
Status
Ongoing
Category
device
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
Lot/Code Info: Lot Code: Model No. 42-5572-066-10 ; UDI-DI (01)00889024561014(17)331103(10)66232947 ; Lot number 66232947
Quantity Affected: 12
Reason for Recall
Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-11
Company
Warsaw, IN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 252 device recalls issued in the same week, part of 389 device-related FDA actions this month.
Zimmer, Inc. has 96 FDA actions in our database, including 71 recalls and 25 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Zimmer, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Zimmer, Inc. have FDA actions?
Zimmer, Inc. has 96 FDA actions in our database, including 71 recalls and 25 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2578-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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