Recall Z-1524-2021 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Encore Medical, LP
DJO EMPOWR KNEE Femoral Sizer
| Date | Feb 5, 2021 |
| Status | Open, Classified |
| Reason | Incorrect assembly of a subcomponent by a vendor and as a result, the windows provided to show the size are facing the opposite direction. |
| Root cause | Nonconforming Material/Component |
| Action | On 02/05/2021, the firm sent an "URGENT FIELD SAFETY NOTICE" Recall letter to customers via e-mail informing them that a product complaint was received where a subcomponent of the sizer was assembled incorrectly. As a result, the windows provided to show the size are facing the opposite direction. When the sizer is in place, the size read from the distal facing side of the instrument is obscured. The risks associated with this issue include: -Delay in surgery -Revision surgery Customers are instructed to the below actions by February 26, 2021: 1. This notice needs to be passed on to all thos |
| Quantity | 16 units |
| Distribution | U.S.: FL, IN, and MN O.U.S.: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143242 | Rebel 3DKNEE System Encore Medical L.P., May 15, 2015 |