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.
This recall is currently active, issued December 7, 2023.
- Recall Initiated
- November 10, 2023
- Posted
- December 7, 2023
- Recall Number
- Z-0508-2024
- Quantity
- 37 devices
- Firm Location
- Austin, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Due to incorrect product/device within packaging.
Distribution
US Nationwide distribution.
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
Root Cause
Labeling Change Control