FDA-Device2026-07-01Class IIPACKAGING DEFECT
Zimmer Persona Revision Femoral Distal Augment recalled for wrong component in package
What this means
Zimmer discovered that 12 units of the Persona Revision Trabecular Metal Femoral Distal Augment (Model 42-5572-066-10, Size 9/9+, 10mm thickness) contained an incorrect posterior augment component in the package instead of the correct distal augment. No patient injuries have been reported.
- If you received this product, do not use it and contact Zimmer immediately with your lot number (66232947) and UDI code.
- Verify the correct component is in your package before surgery.
- Return unused product to Zimmer for replacement.
The agency's original wording
Hazard
Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
12
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2578-2026Want us to check the next one for you?
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