Recall Z-1139-2017 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Encore Medical, Lp
Empowr PS Knee Tibial Insert; Model 343-14-709 The EMPOWR PS tibial insert are made from Highly Cross-Linked Vitamin E (HXL VE) UHMWPE. The tibial insert implants are intended to mate with tibial base implants.
| Date | Feb 3, 2017 (initiated Jan 10, 2017) |
| Status | Terminated |
| Reason | The Empowr PS Insert was reported as missing the impaction slot feature. |
| Root cause | Component design/selection |
| Action | DJO Global sent an Urgent Field Safety Notice dated January 10, 2017, to all affected customers. The Field Safety Notice instructs the agents to notify all individuals within their organization or to any organization where the potentially affected product has been transferred. Customers with questions should contact customer service at 1-800-456-8696. For questions regarding this recall call 512-832-9500. |
| Quantity | 24 units |
| Distribution | Nationwide Distribution to CO, NY, and FL |
| 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 |