Recall Z-0766-2017 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Encore Medical, Lp
Empowr PS Knee System Box Cut Guide The EMPOWER PS Box Cut Guide is 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. |
| Root cause | Device Design |
| Action | DJO Global sent an Urgent Field Safety Notice dated September 19, 2016, to all affected customers. The field safety notice provided a newly revised Surgical Technique to educate users on proper use of the device. Customers were instructed to become familiar with the new surgical techniques and notify all of their applicable users of the revised methods. Customers were also instructed to sign the Acknowledgement and Receipt Form. Customers with questions were advised to call 760-734-3551. For questions regarding this recall call 512-832-6302. |
| Quantity | 162 units |
| Distribution | Nationwide Distribution |
| 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 |