FDA-Device2026-07-01Class IIPACKAGING DEFECT
Zimmer Persona Revision Femoral Distal Augment recalled for wrong component in package
OTHERNationwide distribution
Zimmer Persona Revision augment recalled for packaging error
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.
Hazard
Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.
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-2578-2026More Zimmer, Inc. recalls
- FDA-Device2026-07-01Zimmer Off-Axis Comprehensive Shoulder System reamer guide recalled for breakage risk
- FDA-Device2026-07-01Zimmer Off-Axis Alliance Glenoid Reamer Guide recalled for plastic breakage risk during surgery
- FDA-Device2026-07-01Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444
- FDA-Device2026-07-01Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040242
- FDA-Device2026-07-01Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240
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