Z-2578-2026Class II

Zimmer, Inc.

Recalling firm

Zimmer, Inc.

Product type

Device

Status

Ongoing

Report date

2026-07-01

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.

Firm state

Product quantity

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Documentation & Change Control

Reason for recall

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

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 / lot info

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

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.