Recall Z-2104-2021 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Encore Medical, LP
DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. 11 16mm, CE 0086, Sterile H2O2, UDI: (01)00888912167185
| Date | May 12, 2021 |
| Status | Open, Classified |
| Reason | Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains 16mm knee prosthesis and 16mm knee prosthesis packaging contains 12 mm knee prosthesis. |
| Root cause | Mixed-up of materials/components |
| Action | On 5/12/2021, Encore Medical, LP (DJO) issued a "Urgent Field Safety Notice" via E-Mail. In addition to informing consignees about the recalled product the firm asked consignees to take the following actions by May 26, 2021: 1. This notice needs to be passed on to all those within your organization or to any outside organization or customer where the potentially affected product has been transferred. This recall should be carried out to the user level. 2.Review your stock for the affected products and lot numbers and quarantine the items until returned. 3. Contact Customer Service at 1-80 |
| Quantity | 10 units |
| Distribution | US: Nationwide Distribution in the states of VA, MN, TX, IL, MS, CA, KS, LA, and GA OUS: 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 |