Encore Medical, LP recalls DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341
Recalled Product
DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI: (01)00888912166980
Hazard / Issue
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.
Issued by
FDA
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