Recall Z-0508-2024 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Encore Medical, LP
DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF 243-01-108 DJO surgical EMPOWR KNEE", PRESS FIT BP MINUS, 8L REF 353-03-108 For the treatment of patients who are candidates for knee arthroplasty per the Indication for use.
| Date | Dec 7, 2023 (initiated Nov 10, 2023) |
| Status | Open, Classified |
| Reason | Due to incorrect product/device within packaging. |
| Root cause | Labeling Change Control |
| Quantity | 37 devices |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171991 | EMPOWR Porous Knee System Encore Medical L.P., Oct 4, 2017 |