Recall Z-2125-2025 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 KNEETM INS, 11L 10MM, VE Model/Catalog Number: 341-10-711 Software Version: NA 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 h
| Date | Jul 17, 2025 (initiated Jun 2, 2025) |
| Status | Open, Classified |
| Reason | Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used. |
| Root cause | Packaging change control |
| Action | On 06/02/2025, the firm emailed an "Urgent: Medical Device Recall" letter to customers. The letter described the product, problem and actions to be taken. Customers are instructed to: 1.Review their stock for the products and lot numbers for the items to be returned. 2.This notice needs to be passed on to all those within their organization or to any organization where the product has been transferred. 3.Complete acknowledgement and response form and contact Customer Service at 1-800-456-8696 or through their regional email address, to place a replacement request. They will be provided with a |
| Quantity | 20 |
| Distribution | U.S Distribution to states of: AZ, IA, ID, IL, IN, LA, MI, MO, MS, NE, NY, OK, OR, PR, SD, UT, VA, and WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143242 | Rebel 3DKNEE System Encore Medical L.P., May 15, 2015 |