FDA Recall
Open, Classified
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.
Recall: Z-0508-2024
·
Initiated November 10, 2023
Recall
- Recall Number
- Z-0508-2024
- Event Number
- 93465
- FEI Number
- 1000116912
- Product Code
- MBH
- Status
- Open, Classified
- Root Cause
- Labeling Change Control
- Initiated
- November 10, 2023
- Posted
- December 7, 2023
- Address
- 9800 Metric Blvd, Encore Medical, LP, Austin, TX, 78758-5445
Description
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.
Reason
Due to incorrect product/device within packaging.
Distribution
US Nationwide distribution.
Quantity
37 devices