FDA-Device2023-12-13Class II
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.
Encore Medical, LP
Hazard
Due to incorrect product/device within packaging.
Sold states
US Nationwide distribution.
Affected count
37 devices
Manufactured in
9800 Metric Blvd, Austin, TX, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0508-2024Don't want to check this manually?
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