Recall Z-0325-2017 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Encore Medical, Lp
Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of the posterior stabilized implant.
| Date | Sep 19, 2016 |
| Status | Terminated |
| Reason | It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone removal in the box area, femoral chipping has occurred in surgery. The current design of the captured box cut guides can create an instance where the surgeon is not fully completing the box cut on the side. |
| Root cause | Under Investigation by firm |
| Action | The recalling firm sent a recall notification letter to affected consignees on 9/19/16. The field safety notice provided a newly revised Surgical Technique to educate users on proper use of the device. |
| Quantity | 436 units |
| Distribution | US |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160342 | EMPOWR PS Knee System Encore Medical L.P., May 19, 2016 |