Recall Z-2285-2025 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Encore Medical, LP
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 341-16-704 Product Description: Enovis knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use. While total knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a
| Date | Aug 8, 2025 (initiated Jul 9, 2025) |
| Status | Open, Classified |
| Reason | Knee implants contain incorrect labeling (size and/or side incorrect) |
| Root cause | Labeling Change Control |
| Action | 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 tran |
| Quantity | 18 implants |
| Distribution | US Nationwide distribution in the states of AL, AZ, CA, CO, FL, IA, IL, IN, KS, LA, NY, TN, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143242 | Rebel 3DKNEE System Encore Medical L.P., May 15, 2015 |