medical Class II Updated 2023-12-13

Encore Medical, LP recalls DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porou

Recalled Product

DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF 243-01-108 DJO surgical EMPOWR KNEE", PRESS FIT BP MINUS, 8L REF 353-03-108 For the treatment of patients who are candidates for knee arthroplasty per the Indication for use.

Hazard / Issue

Due to incorrect product/device within packaging.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model Number: 243-01-108 UDI-DI Code: 00190446231295 Lot Number: 277W1114 Model Number: 353-03-108 UDI-DI Code: 00190446231295 Lot Number: 213W1051
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