Zimmer, Inc. recalls Brand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Metal¿ Femoral…

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

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

On May 11, 2026, the firm began notifying consignees via letters titled "URGENT MEDICAL DEVICE RECALL." Customers were instructed to review the notification and ensure affected personnel are aware of the contents. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine affected product. The sales representative will remove the affected product from your facility. If product has been further distributed, provide your customers with the recall notice and ensure documentation.

• FDA enforcement recordOfficial FDA database entry for Z-2578-2026
• FDA 510(k) clearance · K181947The device's official FDA premarket clearance record
• FDA 510(k) clearance · K191625The device's official FDA premarket clearance record
• FDA 510(k) clearance · K210551The device's official FDA premarket clearance record
• FDA device classification · MBHOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3565The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Zimmer, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.