Recall Z-2578-2026— Zimmer, Inc.
Class II · Ongoing
Class II FDA medical device recall by Zimmer, Inc., initiated 2026-05-11. It names 3 FDA 510(k) clearances: K210551, K191625, K181947. 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: Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package..
- Recalling firm
- Zimmer, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-05-11
- Firm location
- Warsaw, IN, United States
510(k) clearances named in this recall
3 on FDA's record- K210551 — Persona Revision Knee System
- K191625 — Persona Revision Knee System
- K181947 — Persona Revision Knee System
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.