FDA-Device2025-08-20Class II
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 7R 16MM, VE Model/Catalog Number: 342-16-707 Product Description: Enovis knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use. While total knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.
Encore Medical, LP
Hazard
Knee implants contain incorrect labeling (size and/or side incorrect)
Sold states
US Nationwide distribution in the states of AL, AZ, CA, CO, FL, IA, IL, IN, KS, LA, NY, TN, TX.
Affected count
40 implants
Manufactured in
9800 Metric Blvd, N/A, Austin, TX, United States
Products
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 7R 16MM, VE Model/Catalog Number: 342-16-707 Product Description: Enovis knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use. While total knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2286-2025Don't want to check this manually?
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