Encore Medical, LP Recall 87942
Description: DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI: (01)00888912166980
Encore Medical, LP Recall 87942 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2103-2021 |
| Event ID | 87942 |
| Event Description | DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI: (01)00888912166980 |
| Product Type | Devices |
| Distribution | US: Nationwide Distribution in the states of VA, MN, TX, IL, MS, CA, KS, LA, and GA OUS: None |
| Quantity | 10 units |
| Recall 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. |
| Device Classification | 20210728 |
| Device Code Info | Lot # 115T1035 |
| Center Classification Date | 20210720 |
| Recall Initiation Date | 20210512 |
| Recalling Firm | Encore Medical, LP |
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