Recall Z-1233-2026 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Encore Medical, LP
EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
| Date | Feb 2, 2026 (initiated Jan 5, 2026) |
| Status | Open, Classified |
| Reason | 942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery. |
| Root cause | Labeling Change Control |
| Action | On 1/5/2026, recall notices were emailed to customers who were asked to do the following: 1) This notice needs to be passed on to all those within your organization or to any organization where the product has been transferred. 2) Contact the firm to arrange for affected device return. 3. Complete and return the acknowledgement and response form via email to Lesli.Helmick@enovis.com Customers with questions can email the firm at productsafety@enovis.com |
| Quantity | 19 |
| Distribution | US: TX, IA, MI, MS, MA, RI, NJ, PA, NY, MO, OK, PR, AL, CA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143242 | Rebel 3DKNEE System Encore Medical L.P., May 15, 2015 |