| Date Initiated by Firm | May 11, 2026 |
|---|
| Date Posted | June 24, 2026 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2578-2026 |
|---|
| Recall Event ID |
99073 |
| 510(K)Number | K181947 K191625 K210551 |
|---|
| Product Classification |
Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer - Product Code MBH
|
| 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 |
|---|
| Code Information |
Lot Code: Model No. 42-5572-066-10 ; UDI-DI (01)00889024561014(17)331103(10)66232947 ; Lot number 66232947
|
| FEI Number |
1000220733
|
Recalling Firm/
Manufacturer |
Zimmer, Inc.
1800 W Center St
Warsaw IN 46580-2304
|
| For Additional Information Contact | 411 Technical Services
800-3482759 |
|---|
Manufacturer Reason
for Recall | Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package. |
|---|
FDA Determined
Cause 2 | Labeling Change Control |
|---|
| Action | 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. |
|---|
| Quantity in Commerce | 12 |
|---|
| 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. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
| 510(K) Database | 510(K)s with Product Code = MBH
|
|---|
