Device 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

Z-2578-2026

May 11, 2026

Class II

Product summary

Firm: Zimmer, Inc.
Event: Event 99073
Status: Ongoing
Classification: Class II
Quantity: 12
Official record key: device-enforcement:Z-2578-2026

Official wording

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

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

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.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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