Recall Z-0041-2018 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Encore Medical, Lp
EMPOWR PS KNEE(TM) e+, REF 343-13-708, SIZE 8, 13mm, QTY 01, SKY BLUE, STERILE Product Usage The EMPOWR PS Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conform to ASTM F2695. This insert is posterior stabilized and is intended to more closely match the kinematics of the k
| Date | Sep 15, 2017 |
| Status | Terminated |
| Reason | It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707. |
| Root cause | Packaging process control |
| Action | The firm initiated the recall by email on 09/05/2017. The letter identified the affected product, problem and actions to be taken. The consignee was directed to notify anyone to whom the product was transferred and to return any in-stock product. |
| Quantity | 48 units |
| Distribution | US 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 |