FDA Device recall Z-2104-2021
DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. 11 16mm, CE 0086, Sterile H2O2, UDI: (01)00888912167185
- FDA Device
- Class II
- ongoing
- Published 2021-07-28
On 2021-07-28 the FDA classified a Class II recall of DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. 11 16mm, CE 0086, Sterile H2O2, UDI: (01)00888912167185 by Encore Medical, citing 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 prosth….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2104-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-05-12 |
| Published | 2021-07-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Encore Medical |
| Distribution | US |
Product
DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. 11 16mm, CE 0086, Sterile H2O2, UDI: (01)00888912167185
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.
Identifiers
| code_info | Lot # 155T1035 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2104-2021%22
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