Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 7R 16MM, VE Model/Catalog Number: 34
FDA device recall Z-2286-2025 · posted 2025-08-08 · Open, Classified
Recall details
- Recalling firm
- Encore Medical, LP
- Reason for recall
- Knee implants contain incorrect labeling (size and/or side incorrect)
- Action taken
- On January 15, 2026 Enovis (Encore Medical, L.P.) issued a Urgent: Medical Device Recall expansion notification to affected consignees via Email. The expansion notification included additional lots of affected product. Initial notification was sent out on July 9, 2025. Enovis asked consignees to take the following actions: 1. Review your stock for the products and lot numbers for the items to be returned. 2. Remove any indicated product from stock and quarantine. 3. This notice needs to be passed on to all those within your organization or to any organization where the product has been transferred. 4. Complete acknowledgement and response form and contact Customer Service at 1-800-456-8696 or through your regional email address, to place a replacement request. You will be provided with an RMA number and shipping label to return the affected product. 5. Return all devices (quantities listed above) using the RMA number and shipping label provided by Customer Service.
- Root cause
- Labeling Change Control
- Status
- Open, Classified
- Product code
- JWH
- Quantity affected
- 40 implants
- Distribution
- US Nationwide distribution in the states of AL, AZ, CA, CO, FL, IA, IL, IN, KS, LA, NY, TN, TX.
- Date initiated
- 2025-07-09
- Date posted
- 2025-08-08
- Location
- Austin, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Rebel 3DKNEE System (K143242) | Encore Medical L.P. | 2015-05-15 |