Z-2578-2026 Class II Ongoing
FDA device recall Z-2578-2026 was initiated by Zimmer, Inc. on May 11, 2026 and is designated Class II. Reason for recall: Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package. The recall status is ongoing. Affected quantity: 12.
Recall Details
- Product Type
- Devices
- Report Date
- July 1, 2026
- Initiation Date
- May 11, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12
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
Reason for Recall
Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.
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.
Code Information
Lot Code: Model No. 42-5572-066-10 ; UDI-DI (01)00889024561014(17)331103(10)66232947 ; Lot number 66232947