Zimmer, Inc.: Brand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment Model/Catalog Number: 42-5572-066-10
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Zimmer, Inc.
- 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
- Reason / hazard
- Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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.
- Recall initiated
- 2026-05-11
- Code info
- Lot Code: Model No. 42-5572-066-10 ; UDI-DI (01)00889024561014(17)331103(10)66232947 ; Lot number 66232947
- Product quantity
- 12
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Warsaw
- State
- IN
- Country
- United States
- Event id
- 99073
Free daily digest + "My products" watchlist