Zimmer, Inc.: Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Recall Summary Zimmer, Inc. is recalling certain Persona Revision Trabecular Metal Femoral Distal Augments (Size 9, 9+, and 10mm thickness) used in knee replacement surgery. A posterior augment was found packaged inside a distal augment package instead of in its correct location. No patient injuries have been reported from this packaging error.
- Recalling firm
- 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
- Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-11
- Status
- Open, Classified
- Distribution
- 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.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/87263ba3-bbd2-4016-a266-78d7e919880e